Senior product expert Vacatures

Over de vacature

Overview

As Senior Product Expert in the Wholesale Banking Advanced Analytics squad, you drive discovery, experimentation and successful shipping of AI-driven data products. You lead a multidisciplinary team to explore opportunities like smart pricing and profitability insights, prioritise the backlog, and guide products from concept to market. You collaborate with UX, Tech, and business stakeholders to validate ideas and deliver measurable value. You will shape product vision in a fast-growing, global environment and inspire data-driven decision making.

Arbeidsvoorwaarden / Benefits

• Hybrid working
• Pension scheme
• 13th month salary
• 8% Holiday payment
• 25-28 vacation days
• Personal growth and challenging work with endless possibilities

Verantwoordelijkheden

• Prioritize the idea backlog for Transaction Services and design/execute experiments to identify problems worth solving
• Ensure solutions are used, trusted and deliver measurable business value by assessing viability, feasibility and desirability
• Bring AI frontier insights into the organization (e.g., smart pricing, transaction network insights, conversational AI)
• Manage intake with Tech, Digital and Wholesale Banking and coordinate stakeholders up to senior management
• Lead a multidisciplinary squad (10+ professionals) to discover, validate, and prototype product ideas and deliver agile outcomes
• Focus on Product and Client Profitability insights to enable sales opportunities across ING's global clients
• Apply Design, Product thinking, Lean and Agile delivery methodologies to mature product management
• Demonstrate thought leadership in data-driven product management, AI product vision and profitability insights in Wholesale Banking
• Maintain enthusiasm for technology, AI and data science methods and translate them into value for the business
• Develop a continuous, observable learning loop to improve products and outcomes

Belangrijkste vereisten

• 8+ years of relevant experience in product management within technology-driven environments

• Proven track record of taking a product from concept to market, including defining vision and strategy for global data products

• Experience with experimentation, discovery and delivering scalable products

• Familiarity with Wholesale Banking or Transaction Services is favorable

• Strong stakeholder management skills, including engaging senior management in Wholesale Banking Transaction Services

• University degree

• English fluent; Dutch optional

• Curiosity and willingness to learn

• Strategic thinking with hands-on execution

• Collaborative and cross-functional leadership

• AI product vision and data-driven product management

• Experimentation and discovery methodologies

• Agile product delivery

Over de vacature

Overview

In this role you will lead enterprise quality controls and process improvements to elevate supplier quality and ensure regulatory compliance. You will coordinate cross-functionally with R&D, manufacturing, and regulatory affairs to close process gaps and maintain high quality standards. You will oversee NPI validations, process development, and control plans while integrating initiatives into site QMS. By analyzing data and COPQ, you drive cost reduction and productivity, and you develop a high-performing quality organization.

Verantwoordelijkheden

• Drive strategic quality initiatives to elevate supplier quality and maintain benchmarks across R&D, manufacturing, and regulatory affairs
• Guide acceptance activities, transfers to manufacturing, and development of NPI validations, process controls, inspection and control plans
• Collaborate with Quality Optimization to embed initiatives into site QMS processes
• Analyze data to identify trends, risks, and improvement opportunities; support process improvements
• Lead cost reduction through COPQ analysis and support cost-saving implementations
• Manage compliance with industry regulations; prepare and maintain regulatory documentation
• Lead talent management, succession planning, and build a high-performing team
• Assess impact to PFMEA and controls with design changes; support manufacturing process development and design transfer
• Mentor quality engineers to support NPI projects and product transfers
• Interact with senior management as a recognized expert across multiple functional areas
• Provide cross-functional leadership with broad experience and project management practices
• Drive succession planning, talent management, and performance/compensation management alignment with goals

Belangrijkste vereisten

• 10+ years in FDA-regulated medical device environments with emphasis on QMS compliance, CAPA, Internal Audit, and CI

• 5+ years of functional/strategic leadership of quality teams in global, matrixed settings

• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards

• Strong understanding of Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer

• Experience leading regulatory inspections (FDA, Notified Bodies)

• Proven leadership in strategic process validation, CAPA, NCs, and QN

• Bachelor's degree in Engineering, Life Sciences, or related field; MBA/MS preferred

• Ability to meet physical, cognitive, and environmental job requirements with/without accommodation

• leadership presence

• cross-functional collaboration

• analytical mindset

• QMS compliance

• CAPA management

• PFMEA and risk management

Over de vacature

Overview

In this role you will lead enterprise quality controls and process improvements to elevate supplier quality and ensure regulatory compliance. You will coordinate cross-functionally with R&D, manufacturing, and regulatory affairs to close process gaps and maintain high quality standards. You will oversee NPI validations, process development, and control plans while integrating initiatives into site QMS. By analyzing data and COPQ, you drive cost reduction and productivity, and you develop a high-performing quality organization.

Verantwoordelijkheden

• Drive strategic quality initiatives to elevate supplier quality and maintain benchmarks across R&D, manufacturing, and regulatory affairs
• Guide acceptance activities, transfers to manufacturing, and development of NPI validations, process controls, inspection and control plans
• Collaborate with Quality Optimization to embed initiatives into site QMS processes
• Analyze data to identify trends, risks, and improvement opportunities; support process improvements
• Lead cost reduction through COPQ analysis and support cost-saving implementations
• Manage compliance with industry regulations; prepare and maintain regulatory documentation
• Lead talent management, succession planning, and build a high-performing team
• Assess impact to PFMEA and controls with design changes; support manufacturing process development and design transfer
• Mentor quality engineers to support NPI projects and product transfers
• Interact with senior management as a recognized expert across multiple functional areas
• Provide cross-functional leadership with broad experience and project management practices
• Drive succession planning, talent management, and performance/compensation management alignment with goals

Belangrijkste vereisten

• 10+ years in FDA-regulated medical device environments with emphasis on QMS compliance, CAPA, Internal Audit, and CI

• 5+ years of functional/strategic leadership of quality teams in global, matrixed settings

• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards

• Strong understanding of Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer

• Experience leading regulatory inspections (FDA, Notified Bodies)

• Proven leadership in strategic process validation, CAPA, NCs, and QN

• Bachelor's degree in Engineering, Life Sciences, or related field; MBA/MS preferred

• Ability to meet physical, cognitive, and environmental job requirements with/without accommodation

• leadership presence

• cross-functional collaboration

• analytical mindset

• QMS compliance

• CAPA management

• PFMEA and risk management

Over de vacature

Overview

In this role you will lead enterprise quality controls and process improvements to elevate supplier quality and ensure regulatory compliance. You will coordinate cross-functionally with R&D, manufacturing, and regulatory affairs to close process gaps and maintain high quality standards. You will oversee NPI validations, process development, and control plans while integrating initiatives into site QMS. By analyzing data and COPQ, you drive cost reduction and productivity, and you develop a high-performing quality organization.

Verantwoordelijkheden

• Drive strategic quality initiatives to elevate supplier quality and maintain benchmarks across R&D, manufacturing, and regulatory affairs
• Guide acceptance activities, transfers to manufacturing, and development of NPI validations, process controls, inspection and control plans
• Collaborate with Quality Optimization to embed initiatives into site QMS processes
• Analyze data to identify trends, risks, and improvement opportunities; support process improvements
• Lead cost reduction through COPQ analysis and support cost-saving implementations
• Manage compliance with industry regulations; prepare and maintain regulatory documentation
• Lead talent management, succession planning, and build a high-performing team
• Assess impact to PFMEA and controls with design changes; support manufacturing process development and design transfer
• Mentor quality engineers to support NPI projects and product transfers
• Interact with senior management as a recognized expert across multiple functional areas
• Provide cross-functional leadership with broad experience and project management practices
• Drive succession planning, talent management, and performance/compensation management alignment with goals

Belangrijkste vereisten

• 10+ years in FDA-regulated medical device environments with emphasis on QMS compliance, CAPA, Internal Audit, and CI

• 5+ years of functional/strategic leadership of quality teams in global, matrixed settings

• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards

• Strong understanding of Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer

• Experience leading regulatory inspections (FDA, Notified Bodies)

• Proven leadership in strategic process validation, CAPA, NCs, and QN

• Bachelor's degree in Engineering, Life Sciences, or related field; MBA/MS preferred

• Ability to meet physical, cognitive, and environmental job requirements with/without accommodation

• leadership presence

• cross-functional collaboration

• analytical mindset

• QMS compliance

• CAPA management

• PFMEA and risk management

Over de vacature

Overview

In this role you will lead enterprise quality controls and process improvements to elevate supplier quality and ensure regulatory compliance. You will coordinate cross-functionally with R&D, manufacturing, and regulatory affairs to close process gaps and maintain high quality standards. You will oversee NPI validations, process development, and control plans while integrating initiatives into site QMS. By analyzing data and COPQ, you drive cost reduction and productivity, and you develop a high-performing quality organization.

Verantwoordelijkheden

• Drive strategic quality initiatives to elevate supplier quality and maintain benchmarks across R&D, manufacturing, and regulatory affairs
• Guide acceptance activities, transfers to manufacturing, and development of NPI validations, process controls, inspection and control plans
• Collaborate with Quality Optimization to embed initiatives into site QMS processes
• Analyze data to identify trends, risks, and improvement opportunities; support process improvements
• Lead cost reduction through COPQ analysis and support cost-saving implementations
• Manage compliance with industry regulations; prepare and maintain regulatory documentation
• Lead talent management, succession planning, and build a high-performing team
• Assess impact to PFMEA and controls with design changes; support manufacturing process development and design transfer
• Mentor quality engineers to support NPI projects and product transfers
• Interact with senior management as a recognized expert across multiple functional areas
• Provide cross-functional leadership with broad experience and project management practices
• Drive succession planning, talent management, and performance/compensation management alignment with goals

Belangrijkste vereisten

• 10+ years in FDA-regulated medical device environments with emphasis on QMS compliance, CAPA, Internal Audit, and CI

• 5+ years of functional/strategic leadership of quality teams in global, matrixed settings

• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards

• Strong understanding of Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer

• Experience leading regulatory inspections (FDA, Notified Bodies)

• Proven leadership in strategic process validation, CAPA, NCs, and QN

• Bachelor's degree in Engineering, Life Sciences, or related field; MBA/MS preferred

• Ability to meet physical, cognitive, and environmental job requirements with/without accommodation

• leadership presence

• cross-functional collaboration

• analytical mindset

• QMS compliance

• CAPA management

• PFMEA and risk management

Over de vacature

Overview

In this role you will lead enterprise quality controls and process improvements to elevate supplier quality and ensure regulatory compliance. You will coordinate cross-functionally with R&D, manufacturing, and regulatory affairs to close process gaps and maintain high quality standards. You will oversee NPI validations, process development, and control plans while integrating initiatives into site QMS. By analyzing data and COPQ, you drive cost reduction and productivity, and you develop a high-performing quality organization.

Verantwoordelijkheden

• Drive strategic quality initiatives to elevate supplier quality and maintain benchmarks across R&D, manufacturing, and regulatory affairs
• Guide acceptance activities, transfers to manufacturing, and development of NPI validations, process controls, inspection and control plans
• Collaborate with Quality Optimization to embed initiatives into site QMS processes
• Analyze data to identify trends, risks, and improvement opportunities; support process improvements
• Lead cost reduction through COPQ analysis and support cost-saving implementations
• Manage compliance with industry regulations; prepare and maintain regulatory documentation
• Lead talent management, succession planning, and build a high-performing team
• Assess impact to PFMEA and controls with design changes; support manufacturing process development and design transfer
• Mentor quality engineers to support NPI projects and product transfers
• Interact with senior management as a recognized expert across multiple functional areas
• Provide cross-functional leadership with broad experience and project management practices
• Drive succession planning, talent management, and performance/compensation management alignment with goals

Belangrijkste vereisten

• 10+ years in FDA-regulated medical device environments with emphasis on QMS compliance, CAPA, Internal Audit, and CI

• 5+ years of functional/strategic leadership of quality teams in global, matrixed settings

• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards

• Strong understanding of Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer

• Experience leading regulatory inspections (FDA, Notified Bodies)

• Proven leadership in strategic process validation, CAPA, NCs, and QN

• Bachelor's degree in Engineering, Life Sciences, or related field; MBA/MS preferred

• Ability to meet physical, cognitive, and environmental job requirements with/without accommodation

• leadership presence

• cross-functional collaboration

• analytical mindset

• QMS compliance

• CAPA management

• PFMEA and risk management

Over de vacature

Overview

In this role you will lead enterprise quality controls and process improvements to elevate supplier quality and ensure regulatory compliance. You will coordinate cross-functionally with R&D, manufacturing, and regulatory affairs to close process gaps and maintain high quality standards. You will oversee NPI validations, process development, and control plans while integrating initiatives into site QMS. By analyzing data and COPQ, you drive cost reduction and productivity, and you develop a high-performing quality organization.

Verantwoordelijkheden

• Drive strategic quality initiatives to elevate supplier quality and maintain benchmarks across R&D, manufacturing, and regulatory affairs
• Guide acceptance activities, transfers to manufacturing, and development of NPI validations, process controls, inspection and control plans
• Collaborate with Quality Optimization to embed initiatives into site QMS processes
• Analyze data to identify trends, risks, and improvement opportunities; support process improvements
• Lead cost reduction through COPQ analysis and support cost-saving implementations
• Manage compliance with industry regulations; prepare and maintain regulatory documentation
• Lead talent management, succession planning, and build a high-performing team
• Assess impact to PFMEA and controls with design changes; support manufacturing process development and design transfer
• Mentor quality engineers to support NPI projects and product transfers
• Interact with senior management as a recognized expert across multiple functional areas
• Provide cross-functional leadership with broad experience and project management practices
• Drive succession planning, talent management, and performance/compensation management alignment with goals

Belangrijkste vereisten

• 10+ years in FDA-regulated medical device environments with emphasis on QMS compliance, CAPA, Internal Audit, and CI

• 5+ years of functional/strategic leadership of quality teams in global, matrixed settings

• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards

• Strong understanding of Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer

• Experience leading regulatory inspections (FDA, Notified Bodies)

• Proven leadership in strategic process validation, CAPA, NCs, and QN

• Bachelor's degree in Engineering, Life Sciences, or related field; MBA/MS preferred

• Ability to meet physical, cognitive, and environmental job requirements with/without accommodation

• leadership presence

• cross-functional collaboration

• analytical mindset

• QMS compliance

• CAPA management

• PFMEA and risk management

Over de vacature

Overview

In this role you will lead enterprise quality controls and process improvements to elevate supplier quality and ensure regulatory compliance. You will coordinate cross-functionally with R&D, manufacturing, and regulatory affairs to close process gaps and maintain high quality standards. You will oversee NPI validations, process development, and control plans while integrating initiatives into site QMS. By analyzing data and COPQ, you drive cost reduction and productivity, and you develop a high-performing quality organization.

Verantwoordelijkheden

• Drive strategic quality initiatives to elevate supplier quality and maintain benchmarks across R&D, manufacturing, and regulatory affairs
• Guide acceptance activities, transfers to manufacturing, and development of NPI validations, process controls, inspection and control plans
• Collaborate with Quality Optimization to embed initiatives into site QMS processes
• Analyze data to identify trends, risks, and improvement opportunities; support process improvements
• Lead cost reduction through COPQ analysis and support cost-saving implementations
• Manage compliance with industry regulations; prepare and maintain regulatory documentation
• Lead talent management, succession planning, and build a high-performing team
• Assess impact to PFMEA and controls with design changes; support manufacturing process development and design transfer
• Mentor quality engineers to support NPI projects and product transfers
• Interact with senior management as a recognized expert across multiple functional areas
• Provide cross-functional leadership with broad experience and project management practices
• Drive succession planning, talent management, and performance/compensation management alignment with goals

Belangrijkste vereisten

• 10+ years in FDA-regulated medical device environments with emphasis on QMS compliance, CAPA, Internal Audit, and CI

• 5+ years of functional/strategic leadership of quality teams in global, matrixed settings

• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards

• Strong understanding of Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer

• Experience leading regulatory inspections (FDA, Notified Bodies)

• Proven leadership in strategic process validation, CAPA, NCs, and QN

• Bachelor's degree in Engineering, Life Sciences, or related field; MBA/MS preferred

• Ability to meet physical, cognitive, and environmental job requirements with/without accommodation

• leadership presence

• cross-functional collaboration

• analytical mindset

• QMS compliance

• CAPA management

• PFMEA and risk management

Over de vacature

Overview

In this role you will lead enterprise quality controls and process improvements to elevate supplier quality and ensure regulatory compliance. You will coordinate cross-functionally with R&D, manufacturing, and regulatory affairs to close process gaps and maintain high quality standards. You will oversee NPI validations, process development, and control plans while integrating initiatives into site QMS. By analyzing data and COPQ, you drive cost reduction and productivity, and you develop a high-performing quality organization.

Verantwoordelijkheden

• Drive strategic quality initiatives to elevate supplier quality and maintain benchmarks across R&D, manufacturing, and regulatory affairs
• Guide acceptance activities, transfers to manufacturing, and development of NPI validations, process controls, inspection and control plans
• Collaborate with Quality Optimization to embed initiatives into site QMS processes
• Analyze data to identify trends, risks, and improvement opportunities; support process improvements
• Lead cost reduction through COPQ analysis and support cost-saving implementations
• Manage compliance with industry regulations; prepare and maintain regulatory documentation
• Lead talent management, succession planning, and build a high-performing team
• Assess impact to PFMEA and controls with design changes; support manufacturing process development and design transfer
• Mentor quality engineers to support NPI projects and product transfers
• Interact with senior management as a recognized expert across multiple functional areas
• Provide cross-functional leadership with broad experience and project management practices
• Drive succession planning, talent management, and performance/compensation management alignment with goals

Belangrijkste vereisten

• 10+ years in FDA-regulated medical device environments with emphasis on QMS compliance, CAPA, Internal Audit, and CI

• 5+ years of functional/strategic leadership of quality teams in global, matrixed settings

• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards

• Strong understanding of Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer

• Experience leading regulatory inspections (FDA, Notified Bodies)

• Proven leadership in strategic process validation, CAPA, NCs, and QN

• Bachelor's degree in Engineering, Life Sciences, or related field; MBA/MS preferred

• Ability to meet physical, cognitive, and environmental job requirements with/without accommodation

• leadership presence

• cross-functional collaboration

• analytical mindset

• QMS compliance

• CAPA management

• PFMEA and risk management

Over de vacature

Overview

In this role you will lead enterprise quality controls and process improvements to elevate supplier quality and ensure regulatory compliance. You will coordinate cross-functionally with R&D, manufacturing, and regulatory affairs to close process gaps and maintain high quality standards. You will oversee NPI validations, process development, and control plans while integrating initiatives into site QMS. By analyzing data and COPQ, you drive cost reduction and productivity, and you develop a high-performing quality organization.

Verantwoordelijkheden

• Drive strategic quality initiatives to elevate supplier quality and maintain benchmarks across R&D, manufacturing, and regulatory affairs
• Guide acceptance activities, transfers to manufacturing, and development of NPI validations, process controls, inspection and control plans
• Collaborate with Quality Optimization to embed initiatives into site QMS processes
• Analyze data to identify trends, risks, and improvement opportunities; support process improvements
• Lead cost reduction through COPQ analysis and support cost-saving implementations
• Manage compliance with industry regulations; prepare and maintain regulatory documentation
• Lead talent management, succession planning, and build a high-performing team
• Assess impact to PFMEA and controls with design changes; support manufacturing process development and design transfer
• Mentor quality engineers to support NPI projects and product transfers
• Interact with senior management as a recognized expert across multiple functional areas
• Provide cross-functional leadership with broad experience and project management practices
• Drive succession planning, talent management, and performance/compensation management alignment with goals

Belangrijkste vereisten

• 10+ years in FDA-regulated medical device environments with emphasis on QMS compliance, CAPA, Internal Audit, and CI

• 5+ years of functional/strategic leadership of quality teams in global, matrixed settings

• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards

• Strong understanding of Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer

• Experience leading regulatory inspections (FDA, Notified Bodies)

• Proven leadership in strategic process validation, CAPA, NCs, and QN

• Bachelor's degree in Engineering, Life Sciences, or related field; MBA/MS preferred

• Ability to meet physical, cognitive, and environmental job requirements with/without accommodation

• leadership presence

• cross-functional collaboration

• analytical mindset

• QMS compliance

• CAPA management

• PFMEA and risk management

Over de vacature

Overview

In this role you will lead enterprise quality controls and process improvements to elevate supplier quality and ensure regulatory compliance. You will coordinate cross-functionally with R&D, manufacturing, and regulatory affairs to close process gaps and maintain high quality standards. You will oversee NPI validations, process development, and control plans while integrating initiatives into site QMS. By analyzing data and COPQ, you drive cost reduction and productivity, and you develop a high-performing quality organization.

Verantwoordelijkheden

• Drive strategic quality initiatives to elevate supplier quality and maintain benchmarks across R&D, manufacturing, and regulatory affairs
• Guide acceptance activities, transfers to manufacturing, and development of NPI validations, process controls, inspection and control plans
• Collaborate with Quality Optimization to embed initiatives into site QMS processes
• Analyze data to identify trends, risks, and improvement opportunities; support process improvements
• Lead cost reduction through COPQ analysis and support cost-saving implementations
• Manage compliance with industry regulations; prepare and maintain regulatory documentation
• Lead talent management, succession planning, and build a high-performing team
• Assess impact to PFMEA and controls with design changes; support manufacturing process development and design transfer
• Mentor quality engineers to support NPI projects and product transfers
• Interact with senior management as a recognized expert across multiple functional areas
• Provide cross-functional leadership with broad experience and project management practices
• Drive succession planning, talent management, and performance/compensation management alignment with goals

Belangrijkste vereisten

• 10+ years in FDA-regulated medical device environments with emphasis on QMS compliance, CAPA, Internal Audit, and CI

• 5+ years of functional/strategic leadership of quality teams in global, matrixed settings

• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards

• Strong understanding of Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer

• Experience leading regulatory inspections (FDA, Notified Bodies)

• Proven leadership in strategic process validation, CAPA, NCs, and QN

• Bachelor's degree in Engineering, Life Sciences, or related field; MBA/MS preferred

• Ability to meet physical, cognitive, and environmental job requirements with/without accommodation

• leadership presence

• cross-functional collaboration

• analytical mindset

• QMS compliance

• CAPA management

• PFMEA and risk management

Over de vacature

Overview

In this role you will lead enterprise quality controls and process improvements to elevate supplier quality and ensure regulatory compliance. You will coordinate cross-functionally with R&D, manufacturing, and regulatory affairs to close process gaps and maintain high quality standards. You will oversee NPI validations, process development, and control plans while integrating initiatives into site QMS. By analyzing data and COPQ, you drive cost reduction and productivity, and you develop a high-performing quality organization.

Verantwoordelijkheden

• Drive strategic quality initiatives to elevate supplier quality and maintain benchmarks across R&D, manufacturing, and regulatory affairs
• Guide acceptance activities, transfers to manufacturing, and development of NPI validations, process controls, inspection and control plans
• Collaborate with Quality Optimization to embed initiatives into site QMS processes
• Analyze data to identify trends, risks, and improvement opportunities; support process improvements
• Lead cost reduction through COPQ analysis and support cost-saving implementations
• Manage compliance with industry regulations; prepare and maintain regulatory documentation
• Lead talent management, succession planning, and build a high-performing team
• Assess impact to PFMEA and controls with design changes; support manufacturing process development and design transfer
• Mentor quality engineers to support NPI projects and product transfers
• Interact with senior management as a recognized expert across multiple functional areas
• Provide cross-functional leadership with broad experience and project management practices
• Drive succession planning, talent management, and performance/compensation management alignment with goals

Belangrijkste vereisten

• 10+ years in FDA-regulated medical device environments with emphasis on QMS compliance, CAPA, Internal Audit, and CI

• 5+ years of functional/strategic leadership of quality teams in global, matrixed settings

• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards

• Strong understanding of Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer

• Experience leading regulatory inspections (FDA, Notified Bodies)

• Proven leadership in strategic process validation, CAPA, NCs, and QN

• Bachelor's degree in Engineering, Life Sciences, or related field; MBA/MS preferred

• Ability to meet physical, cognitive, and environmental job requirements with/without accommodation

• leadership presence

• cross-functional collaboration

• analytical mindset

• QMS compliance

• CAPA management

• PFMEA and risk management

Over de vacature

Overview

In this role you will lead enterprise quality controls and process improvements to elevate supplier quality and ensure regulatory compliance. You will coordinate cross-functionally with R&D, manufacturing, and regulatory affairs to close process gaps and maintain high quality standards. You will oversee NPI validations, process development, and control plans while integrating initiatives into site QMS. By analyzing data and COPQ, you drive cost reduction and productivity, and you develop a high-performing quality organization.

Verantwoordelijkheden

• Drive strategic quality initiatives to elevate supplier quality and maintain benchmarks across R&D, manufacturing, and regulatory affairs
• Guide acceptance activities, transfers to manufacturing, and development of NPI validations, process controls, inspection and control plans
• Collaborate with Quality Optimization to embed initiatives into site QMS processes
• Analyze data to identify trends, risks, and improvement opportunities; support process improvements
• Lead cost reduction through COPQ analysis and support cost-saving implementations
• Manage compliance with industry regulations; prepare and maintain regulatory documentation
• Lead talent management, succession planning, and build a high-performing team
• Assess impact to PFMEA and controls with design changes; support manufacturing process development and design transfer
• Mentor quality engineers to support NPI projects and product transfers
• Interact with senior management as a recognized expert across multiple functional areas
• Provide cross-functional leadership with broad experience and project management practices
• Drive succession planning, talent management, and performance/compensation management alignment with goals

Belangrijkste vereisten

• 10+ years in FDA-regulated medical device environments with emphasis on QMS compliance, CAPA, Internal Audit, and CI

• 5+ years of functional/strategic leadership of quality teams in global, matrixed settings

• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards

• Strong understanding of Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer

• Experience leading regulatory inspections (FDA, Notified Bodies)

• Proven leadership in strategic process validation, CAPA, NCs, and QN

• Bachelor's degree in Engineering, Life Sciences, or related field; MBA/MS preferred

• Ability to meet physical, cognitive, and environmental job requirements with/without accommodation

• leadership presence

• cross-functional collaboration

• analytical mindset

• QMS compliance

• CAPA management

• PFMEA and risk management

Over de vacature

Overview

In this role you will lead enterprise quality controls and process improvements to elevate supplier quality and ensure regulatory compliance. You will coordinate cross-functionally with R&D, manufacturing, and regulatory affairs to close process gaps and maintain high quality standards. You will oversee NPI validations, process development, and control plans while integrating initiatives into site QMS. By analyzing data and COPQ, you drive cost reduction and productivity, and you develop a high-performing quality organization.

Verantwoordelijkheden

• Drive strategic quality initiatives to elevate supplier quality and maintain benchmarks across R&D, manufacturing, and regulatory affairs
• Guide acceptance activities, transfers to manufacturing, and development of NPI validations, process controls, inspection and control plans
• Collaborate with Quality Optimization to embed initiatives into site QMS processes
• Analyze data to identify trends, risks, and improvement opportunities; support process improvements
• Lead cost reduction through COPQ analysis and support cost-saving implementations
• Manage compliance with industry regulations; prepare and maintain regulatory documentation
• Lead talent management, succession planning, and build a high-performing team
• Assess impact to PFMEA and controls with design changes; support manufacturing process development and design transfer
• Mentor quality engineers to support NPI projects and product transfers
• Interact with senior management as a recognized expert across multiple functional areas
• Provide cross-functional leadership with broad experience and project management practices
• Drive succession planning, talent management, and performance/compensation management alignment with goals

Belangrijkste vereisten

• 10+ years in FDA-regulated medical device environments with emphasis on QMS compliance, CAPA, Internal Audit, and CI

• 5+ years of functional/strategic leadership of quality teams in global, matrixed settings

• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards

• Strong understanding of Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer

• Experience leading regulatory inspections (FDA, Notified Bodies)

• Proven leadership in strategic process validation, CAPA, NCs, and QN

• Bachelor's degree in Engineering, Life Sciences, or related field; MBA/MS preferred

• Ability to meet physical, cognitive, and environmental job requirements with/without accommodation

• leadership presence

• cross-functional collaboration

• analytical mindset

• QMS compliance

• CAPA management

• PFMEA and risk management

Over de vacature

Overview

In this role you will lead enterprise quality controls and process improvements to elevate supplier quality and ensure regulatory compliance. You will coordinate cross-functionally with R&D, manufacturing, and regulatory affairs to close process gaps and maintain high quality standards. You will oversee NPI validations, process development, and control plans while integrating initiatives into site QMS. By analyzing data and COPQ, you drive cost reduction and productivity, and you develop a high-performing quality organization.

Verantwoordelijkheden

• Drive strategic quality initiatives to elevate supplier quality and maintain benchmarks across R&D, manufacturing, and regulatory affairs
• Guide acceptance activities, transfers to manufacturing, and development of NPI validations, process controls, inspection and control plans
• Collaborate with Quality Optimization to embed initiatives into site QMS processes
• Analyze data to identify trends, risks, and improvement opportunities; support process improvements
• Lead cost reduction through COPQ analysis and support cost-saving implementations
• Manage compliance with industry regulations; prepare and maintain regulatory documentation
• Lead talent management, succession planning, and build a high-performing team
• Assess impact to PFMEA and controls with design changes; support manufacturing process development and design transfer
• Mentor quality engineers to support NPI projects and product transfers
• Interact with senior management as a recognized expert across multiple functional areas
• Provide cross-functional leadership with broad experience and project management practices
• Drive succession planning, talent management, and performance/compensation management alignment with goals

Belangrijkste vereisten

• 10+ years in FDA-regulated medical device environments with emphasis on QMS compliance, CAPA, Internal Audit, and CI

• 5+ years of functional/strategic leadership of quality teams in global, matrixed settings

• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards

• Strong understanding of Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer

• Experience leading regulatory inspections (FDA, Notified Bodies)

• Proven leadership in strategic process validation, CAPA, NCs, and QN

• Bachelor's degree in Engineering, Life Sciences, or related field; MBA/MS preferred

• Ability to meet physical, cognitive, and environmental job requirements with/without accommodation

• leadership presence

• cross-functional collaboration

• analytical mindset

• QMS compliance

• CAPA management

• PFMEA and risk management