We are seeking a
Quality Assurance Specialist to join a fast-paced and quality-driven medical device environment based in
Flevoland, Netherlands. The ideal candidate will have deep expertise in
ISO 13485, MDR, MDSAP, and CAPA systems, with a passion for maintaining and enhancing Quality Management Systems (QMS) across the product lifecycle. This role plays a critical part in supporting both compliance and continuous improvement initiatives, while actively collaborating with cross-functional teams to ensure product and process quality.
Company Description:
Our client is a dynamic and innovative organization operating within the medical device industry, with a strong focus on the design, development, and production of
Class III implantable devices. With full in-house manufacturing capabilities and a commitment to the highest standards of quality, they prioritize patient safety, product performance, and global regulatory compliance.
Essential Requirements:
- Minimum 3 years of experience in QA within medical device or other regulated life sciences sectors
- Strong knowledge of ISO 13485, MDR, and global quality and regulatory frameworks (e.g., MDSAP, 21 CFR Part 820)
- Proven experience leading and closing CAPAs using structured root cause analysis tools (e.g., 5 Whys, Fishbone)
- Expertise in change control processes for engineering, manufacturing, and documentation
- Ability to review and approve technical documentation including SOPs, batch records, validation reports
- Skilled in internal audits and confident in supporting external inspections (e.g., Notified Body audits)
- Hands-on experience working in cleanroom manufacturing environments
- Solid technical writing skills and proficiency in Microsoft Office Suite
- Professional-level English language proficiency
Desirable Requirements:
- Previous participation in Notified Body audits
- Auditor training in ISO 13485 or ISO 9001
- Familiarity with eQMS platforms
- Knowledge of UDI and international labeling requirements
- Working knowledge of GMP/GDP principles
- Understanding of product lifecycle from design controls to post-market activities
- High precision in document review to ensure compliance and technical accuracy
Next Steps:
If you're ready to take the next step in your Quality Assurance career and contribute to an innovative medical device organization, we would love to hear from you. Apply today to express your interest - interviews are being scheduled on a rolling basis, so early applications are strongly encouraged.
For more information or a confidential conversation about this opportunity, please don’t hesitate to get in touch.