Quality Engineer

We are currently looking for a Quality Engineer to join a leading Pharmaceutical company based in the Cambridge area. As the Quality Engineer, you will be responsible for ensuring the highest standards of design control and risk management throughout the product lifecycle.

This is an initial 12 month contract and hybrid working can be offered.

Your duties as the Quality Engineer will be varied however the key duties and responsibilities are as follows:

1. As the Quality Engineer, you will 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.

2. As the Quality Engineer, you will Support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.

3. As the Quality Engineer, you will Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.

4. As the Quality Engineer, you will Provide input and support to design validation including, but not limited to, human factors engineering assessments.

To be successful in your application to this exciting role as the Quality Engineer we are looking to identify the following on your profile and past history:

1. Relevant degree in a science or engineering discipline such as chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, or chemical engineering.

2. Proven industry experience in pharmaceutical combination product / drug delivery and/or device industries.

3. 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: Quality Engineer / Compliance / Biotherapeutics / Pharmaceutical / Cambridge / Design Control / Risk Management / Medical Device / Combination Product / Regulatory Standards