Senior Quality Assurance Manager - Medical Devices | SEC Life Sciences

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Senior Quality Assurance Manager - Medical Devices

  • Negotiable
  • Gothenburg
  • Permanent

A global leader in dental products and technologies, with over 100 years of life science innovation under their belt, is seeking a Senior Manager QA for its advanced facility just outside of Gothenburg.

You'll play a pivotal role in a dynamic environment, contributing to the company's longstanding commitment to oral health and the wider medical device sector.

As Senior QA Manager, you will:

  • Oversee the quality management system, ensuring compliance with FDA, MDR/MDD, and other regulatory standards.
  • Lead regulatory authority audits.
  • Ensure validation and verification of products and processes.
  • Maintain a validation system for new products and processes in accordance with current standards.
  • Collaborate closely with Manufacturing, Engineering, and R&D teams.
  • Promote continuous improvement in QA functions.
  • Manage the QA team, aligning with the Quality Strategy and business objectives.
  • Handle the QA department's budget and personnel management.

The ideal candidate should have:

  • Extensive experience in Quality Assurance/Control in the medical device industry.
  • Knowledge of US FDA 21 CFR Part 820 and ISO 13485:2016.
  • Familiarity with EU Medical Device Regulation (EU) 2017/745.
  • Experience in Notified Body Audits and FDA Inspections.
  • Managerial experience, including personnel and budget oversight.

Candidates are encouraged to apply immediately for this crucial role. This position offers an exceptional opportunity to contribute significantly to a field that impacts lives across the globe. For more information or similar roles in the sector, please get in touch.

Isobel Abernethy Associate Consultant

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