Quality Assurance Engineer

2 months ago


Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full time

**Job Title:** Quality Assurance Engineer

Estimated Salary: £50,000 - £70,000 per annum

Clinical Professionals Limited is seeking a highly skilled Quality Assurance Engineer to join our team in Cambridge. As a key member of our Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence, you will be responsible for leading design control and risk management activities for combination product development programs.

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 facilitate 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.

Requirements:

  • BSc in 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
  • OR MSc in 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
  • OR PhD in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline)
  • 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
  • Understand Good Manufacturing Practices (GMP)


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