Apply for the Quality Engineer role at Hyper Recruitment Solutions.
Cambridge, England, United Kingdom.
This is a 12‑month contract with an initially hybrid working arrangement (50% onsite).
Key Duties and Responsibilities
* Lead design control and risk management activities for combination product development programmes, 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.
* Provide input and support to design validation including, but not limited to, human factors engineering assessments.
Role Requirements
* Relevant degree in a science or engineering discipline such as chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, or chemical engineering.
* Proven industry experience in the pharmaceutical combination product and/or device industries.
* A working knowledge and practical experience with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
Key Words: Design Control, Risk Management, Medical Device, Combination Product, Pharmaceutical, Cambridge, Quality Standards, Regulatory Compliance, Human Factors Engineering.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer.
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