Director, Process Compliance & Centers of Excellence

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

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