QA Officer Medical Devices

Over onze klant

Our client is an innovative and fast-growing company within the medical devices industry. With a strong focus on patient safety and product quality, they operate internationally and are known for their collaborative and mission-driven culture.

• Lead and coordinate operational quality meetings (e.g. planning, CAPA, blocked products).
• Proactively engage with internal teams and (co-)manufacturers on quality issues.
• Handle and follow up on complaints, non-conformities, and quality events.
• Participate in internal and external audits.
• Execute product release processes in line with internal procedures.
• Monitor bioburden and pyrogen levels regularly.
• Archive quality documentation (e.g. batch records) per procedures.
• Act as ERP system expert within the quality team.
• Write, review, and update QMS procedures and QA documentation.
• Promote a strong quality culture across the organization.

• Holds a relevant technical education (MBO/MBO+ or equivalent).
• Has at least 2 years of experience in a QA role within Pharma, Food, or Medical Devices.
• Possesses strong analytical skills and a structured way of working.
• Communicates clearly and proactively with different stakeholders.
• Is pragmatic, flexible, and resilient under pressure.
• Has knowledge of ISO 13485 and Medical Device Regulations (preferred).
• Is fluent in English, both written and spoken & Dutch is preferred.
• Is proficient with Microsoft Office tools (Word, Excel, Outlook, PowerPoint).
• Shows ownership and takes initiative to improve quality processes.
• Acts as a quality ambassador, fostering a culture of compliance and excellence.

• A key role in a growing, international medical device company.
• A dynamic and collaborative work environment.
• The opportunity to make real impact on product quality and patient safety.
• Professional growth and development opportunities.
• Competitive salary and benefits package.
• Flexible working hours and a good work-life balance.
• A role based in Almelo, with a strong and supportive QA team.