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Medical device auditor iso 13485 mdsap mdr Vacatures

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Medical Devices Auditor - Active, Software. Dutch speaking

bij BSI Group - Utrecht
op website van werkgever
Dienstverband
Fulltime
Werklocatie
Flex
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever

Medical Devices Auditor - Active, Software. Dutch speaking

op website van werkgever
Dienstverband
Fulltime
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever

Medical Devices Auditor - Active, Software. Dutch speaking

bij BSI Group in Rotterdam - Zuid-Holland
op website van werkgever
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever

Medical Devices Auditor - Active, Software. Dutch speaking

bij BSI Group in Eindhoven - Noord-Brabant
op website van werkgever
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever

Medical Devices Auditor - Active, Software. Dutch speaking

bij BSI Group in Den Haag - Zuid-Holland
op website van werkgever
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever

Medical Devices Auditor - Active, Software. Dutch speaking

bij BSI Group in Breda - Noord-Brabant
op website van werkgever
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever

Medical Devices Auditor - Active, Software. Dutch speaking

bij BSI Group in Zwolle - Overijssel
op website van werkgever
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever

Medical Devices Auditor - Active, Software. Dutch speaking

bij BSI Group in 's-Hertogenbosch - Noord-Brabant
op website van werkgever
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever

Medical Devices Auditor - Active, Software. Dutch speaking

bij BSI Group in Apeldoorn - Gelderland
op website van werkgever
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever

Medical Devices Auditor - Active, Software. Dutch speaking

bij BSI Group in Tilburg - Noord-Brabant
op website van werkgever
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever

Medical Devices Auditor - Active, Software. Dutch speaking

bij BSI Group in Amersfoort - Utrecht
op website van werkgever
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever

Medical Devices Auditor - Active, Software. Dutch speaking

bij BSI Group in Arnhem - Gelderland
op website van werkgever
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever

Medical Devices Auditor - Active, Software. Dutch speaking

bij BSI Group in Almere - Flevoland
op website van werkgever
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever

Medical Devices Auditor - Active, Software. Dutch speaking

bij BSI Group in Nijmegen - Gelderland
op website van werkgever
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever

Medical Devices Auditor - Active, Software. Dutch speaking

bij BSI Group in Haarlem - Noord-Holland
op website van werkgever
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI's mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.

Arbeidsvoorwaarden / Benefits

  • 27 days annual leave
  • paid sick leave
  • pension plan
  • company car
  • healthcare allowance
  • paid parental leave

Verantwoordelijkheden

  • Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
  • Observe audits initially, then conduct audits independently
  • Audit on-site, remotely or in hybrid setups
  • Write audit reports and coordinate with planning team and delivery manager
  • Manage clients and audit schedules; perform related administrative tasks

Belangrijkste vereisten

  • minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production

  • at least 2 years' experience with quality management systems

  • university or technical college degree in a related STEM subject (BSc, MSc or PhD)

  • native or high level proficiency in Dutch and English

  • ability to travel 70-75% within EMEA

  • ISO 13485 Lead Auditor training

  • MDSAP

  • MDR (Medical Device Regulation)

  • ability to conduct audits (on-site/remotely/hybrid)

  • conformity assessment activities for UKCA and CE marking

Direct solliciteren
solliciteer op website van werkgever