Back to searchQuality Engineer
Hyper Recruitment Solutions LTD
Posted 8 days ago, valid for 18 days
Cambridge, Cambridgeshire CB234LR, England
£20 - £26 per hour
Full Time
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Sonic Summary
- Our client, a leading Pharmaceutical Company in Cambridgeshire, is looking for a Quality Engineer for an initial 12-month contract with a salary of £40,000 to £50,000 per annum.
- The Quality Engineer will provide expertise in medical device and combination product development throughout the product lifecycle.
- Key responsibilities include leading design control and risk management activities, ensuring compliance with quality and regulatory standards, and supporting design validation efforts.
- Candidates should have a relevant degree in a science or engineering discipline and proven industry experience in the pharmaceutical combination product and/or device industries.
- A working knowledge of ISO 13485, ISO 14971, and other regulatory frameworks is essential for this role.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Engineerwill be varied however the key duties and responsibilities are as follows:
1. As the Quality Engineer, you willlead 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. As the Quality Engineer, you willsupport and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
3. As the Quality Engineer, you willensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
4. As the Quality Engineer, you willprovide input and support to design validation including, but not limited to, human factors engineering assessments.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Quality Engineerwe 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 the pharmaceutical combination product 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:
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. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
