Quality Assurance Specialist

3 hours ago

Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time
Quality Engineer

Cpl Life Sciences is seeking a highly skilled Quality Engineer to join our team in Cambridge, UK.

About the Role:

We are looking for a Quality Engineer to provide design control and risk management subject matter expertise to medical device and combination product development programmes throughout the product lifecycle.

Key Responsibilities:

  • Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
  • Support and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
  • Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
  • Provide input and support to design validation including, but not limited to, human factors engineering assessments.
  • Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply.
  • Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
  • Support the generation of all regulatory submission data and content for assigned device projects.

Requirements:

We are looking for a candidate with a BSc in an appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries.

Alternatively, a MSc or PhD in an appropriate science & engineering discipline with relevant experience is also acceptable.

The ideal candidate will have a history of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.

They will also have a good understanding of Good Manufacturing Practices (GMP).

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