Quality Engineer

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Recruitment Team Leader - Client Services - Hyper Recruitment Solutions

Our client is seeking a dedicated Quality Engineer to join a leading pharmaceutical company based in Cambridgeshire. As the Quality Engineer, you will be instrumental in providing design control and risk management expertise for medical devices and combination products.

KEY DUTIES AND RESPONSIBILITIES:

1. 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.
2. Support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
3. Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
4. Provide input and support to design validation, including human factors engineering assessments.

ROLE REQUIREMENTS:

1. Relevant degree in a science or engineering discipline (e.g., chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering).
2. Proven industry experience in the pharmaceutical combination product and/or medical device industries.
3. Working knowledge and practical experience with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Science, Manufacturing, and Quality Assurance

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Engineering Services

Location

Cambridge, England, United Kingdom

Key Words

Quality Engineer / Biotherapeutics / Pharmaceutical / Cambridge / Design Control / Risk Management / Combination Products / Medical Devices / Regulatory Compliance / Human Factors Engineering

HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements.

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