Quality Assurance Specialist

Zürich
Unbefristet
Vollzeit

30 Tage her

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

Panda International

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