Seeking a Quality Assurance Specialist to thrive in a dynamic medical device setting. This role is pivotal in enhancing Quality Management Systems and driving compliance and improvement initiatives. Collaborate with cross-functional teams to ensure top-notch product and process quality. The company excels in designing and manufacturing Class III implantable devices, prioritizing patient safety and global regulatory compliance. Join now and make a significant impact in the medical device industry! Explore the possibilities and discover your next career move.

Over het bedrijf

Panda International

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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.

Gerelateerde zoekopdrachten

Kwaliteitsmedewerker Almere Fulltime Almere Vast contract Almere Almere Provincie Flevoland Kwaliteitsmedewerker Salaris Kwaliteitsmedewerker

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