Quality Engineer

Cpl Life Sciences; Cambridge; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading company in medical device development is seeking an experienced Quality Engineer to contribute to product development. The role involves working throughout the full product life cycle and ensuring compliance with industry standards. Candidates should possess a relevant degree and experience with ISO standards relevant to medical devices.

Qualifications

• Experience with design controls and risk management for combination products.
• Familiarity with device assembly manufacturing processes.
• Understanding of Human Factors Engineering and Usability Engineering.

Responsibilities

• Work on the full product life cycle and collaborate with cross-functional teams.
• Ensure compliance with relevant ISO standards and regulations.
• Manage multiple tasks simultaneously while maintaining high technical detail.

Skills

Attention to detail

Collaboration

Communication (oral, written, presentation)

Education

Relevant Degree or Higher Education Qualification

Tools

ISO 9001

ISO 13485

ISO 14971

21 CFR 820

21 CFR 4

EU Medical Devices Regulation

Good Manufacturing Practices (GMP)

Job description

We are looking for an experienced Quality Engineer to join the team of an established Device Development Centre. The role will entail working on the full product life cycle, cross-functionally with various teams and stakeholders involved.

Experience

• Relevant Degree or Higher Education Qualification
• History of working in accordance with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation
• Experience in design controls and risk management for combination products
• Familiar with Human Factors Engineering – Usability Engineering
• Familiar with device assembly manufacturing processes

Technical Skills Requirements

• Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation
• Familiarity with EN 62366, EN 60601, and EN 62304
• Ability to learn and apply established procedures reliably and consistently
• Capable of working independently with minimal supervision
• High attention to technical details and accuracy
• Ability to prioritize multiple responsibilities and manage multiple tasks simultaneously
• Strong collaboration skills in cross-functional teams
• Excellent communication (oral, written, presentation) and interpersonal skills
• Proficiency in general computer software such as word processing, spreadsheets, and presentations
• Understanding of Good Manufacturing Practices (GMP)

Application Process

To apply, please submit your full name, email address, cover message (optional), and upload your CV and any relevant files. You may also opt to be contacted via SMS.

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This job posting was created on 22/06/2025 by TN United Kingdom.