Quality Engineer - 12m contract
Posted 1 week ago by Cpl Life Sciences
Negotiable
Inside
Onsite
Cambridge, England, United Kingdom
Summary: Cpl Life Sciences is seeking a Quality Engineer for a global Pharmaceutical organization in Cambridge, focusing on combination products and medical devices. The role involves providing design control and risk management expertise throughout the product development lifecycle. Candidates should have experience in generating and reviewing design history files and risk management files while collaborating with various teams. This is a PAYE contract position requiring on-site presence approximately 2.5 days per week.
Key Responsibilities:
- Lead risk management (ISO 14971) and design control activities.
- Ensure product development activities are compliant with quality and regulatory standards.
- Provide support to design validation/human factors engineering teams.
- Support design and manufacturing investigations.
- Support internal and external audits from a product development engineering stance.
Key Skills:
- BSc in appropriate science & engineering discipline with a minimum of 5 years of relevant experience in the pharmaceutical combination product and/or device industries.
- Knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Ideally experience in design controls for combination products.
- Familiar with Human Factors Engineering - Usability Engineering.
- Familiar with medical device manufacturing processes.
Salary (Rate): undetermined
City: Cambridge
Country: United Kingdom
Working Arrangements: on-site
IR35 Status: inside IR35
Seniority Level: undetermined
Industry: Other
Cpl Life Sciences are looking to recruit a Quality Engineer to join a global Pharmaceutical organisation based in Cambridge. This role sits within their combination product team - combination product or medical device experience are highly desirable. This role will provide design control and risk management expertise to medical device and combination product development projects, from initial design through to manufacturing. This role heavily involves generation and review of DHF/risk management files, working alongside device development leads, design engineers and human factors SME's. This role is a PAYE contract - 12m You will be expected to be present at the Cambridge site (average of 2.5 days per week/5 days per fortnight).
Responsibilities include:
- Lead risk management (ISO 14971) and design control activities.
- Ensure product development activities are compliant with quality and regulatory standards.
- Provide support to design validation/human factors engineering teams.
- Support design and manufacturing investigations.
- Support internal and external audits from a product development engineering stance.
Skills and qualifications:
- BSc in appropriate science & engineering discipline with a minimum of 5 years of relevant experience in the pharmaceutical combination product and/or device industries
- Knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Ideally experience in design controls for combination products.
- Familiar with Human Factors Engineering - Usability Engineering.
- Familiar with medical device manufacturing processes.
If interested, please apply directly or email your CV to megan.smyth@cpl.com