MedTech Quality Engineer - ISO 13485, GMP & CAPA Lead

g2 Recruitment; Bergen op Zoom; On-site; EUR 60,000 - 80,000; Full time

Job summary

g2 Recruitment is seeking a Quality Engineer for a permanent role in the Netherlands, focusing on GMP, QA documentation and CAPA management, with close collaboration with engineering and manufacturing teams.

Ideal candidates have ISO 13485 experience and MDR knowledge, plus a background in medical device manufacturing or pharmaceuticals. Fluency in Dutch is essential for this position located in Zeeland.

Qualifications

• Bachelor's degree in an engineering or scientific discipline.
• Background as QA Officer, Specialist, Quality Engineer, or similar.
• Experience working on QA, documentation, GMP, CAPAs and GLP.
• Working history in the Medical Manufacturing sector strongly preferred, pharmaceuticals can also be considered.
• Experience working with ISO 13485 essential.
• MDR Knowledge.
• Ability to work independently, coordinating multiple processes simultaneously.
• Fluent Dutch is essential.

Responsibilities

• Lead quality activities and coordinate with engineering and manufacturing.
• Ensure GMP standards and CAPA processes are followed.
• Support ISO 13485 compliance and GMP documentation.

Skills

Quality Assurance

GMP compliance

CAPA handling

Root cause analysis

Education

Bachelor's degree in engineering or science

Tools

ISO 13485

MDR Knowledge

Job description

g2 Recruitment is seeking a Quality Engineer for a permanent role in the Netherlands, focusing on GMP, QA documentation and CAPA management, with close collaboration with engineering and manufacturing teams.

Ideal candidates have ISO 13485 experience and MDR knowledge, plus a background in medical device manufacturing or pharmaceuticals. Fluency in Dutch is essential for this position located in Zeeland.