Quality Assurance Specialist
Panda International
Quality Assurance Specialist
Samenvatting
Wat krijg je?
Wat ga je doen?
- Ondersteunen en verbeteren van het QMS
- Kwaliteitsdocumentatie en SOP's ontwikkelen
- Deelnemen aan audits en leverancierskwalificatie
- Assisteren bij CAPA en klachtenafhandeling
- Naleving ISO 13485 en EU MDR waarborgen
Wat verwachten wij?
- Hbo- of wo-opleiding in de Life Sciences
- Minimaal 5 jaar ervaring in medische hulpmiddelen
- Grondige vakkennis van ISO 13485-normen
- Goede kennis van de EU MDR-regelgeving
Volledige vacaturetekst
Join a leading medical device company focused on strengthening its QMS and ensuring full EU MDR compliance. In this role, you contribute to the implementation of ISO 13485 standards and handle crucial regulatory activities such as EUDAMED submissions and technical documentation. You will collaborate cross-functionally within a high-stakes environment where quality is the core priority. Dive into this specialized field and help shape the future of medical safety today!
Quality Assurance Specialist
We are currently supporting a medical device company that is strengthening its QMS to ensure full compliance with EU regulatory requirements and continuous process improvement.
To support this initiative, we are seeking a Quality Assurance & Regulatory Compliance Consultant to contribute to the implementation and maintenance of an ISO 13485-based QMS while supporting regulatory compliance activities under EU MDR (2017/745).
Responsibilities
- Support the implementation, maintenance, and continuous improvement of the QMS
- Develop and maintain quality documentation (SOPs, forms, records)
- Support supplier qualification activities and participate in internal and external audits
- Assist in CAPA management, complaint handling, and non-conformity processes
- Ensure compliance with ISO 13485 and EU MDR (2017/745)
- Support technical documentation maintenance and regulatory compliance activities
- Contribute to PMS and vigilance processes
- Verify labelling, packaging, and regulatory documentation compliance
- Support regulatory registrations and database submissions (e.g. UDI / EUDAMED where applicable)
- Collaborate cross-functionally to ensure adherence to quality and compliance standards
Your Profile
- Degree in Biomedical Engineering, Biotechnology, Life Sciences, or related field
- Minimum 5 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device
- Strong working knowledge of ISO 13485
- Good understanding of EU MDR (2017/745)
- Experience with Risk Management (ISO 14971)
- Experience supporting audits (internal and external)
- Fluency in English, written and spoken
Over de werkgever
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