Home
Jobs
BioTalent
Quality Engineer

Quality Engineer

Hybrid

Cambridge, United kingdom

£ 26 /hour

Freelance

04-11-2025

Share this job:

Score my CV

Skills

Communication Risk Management

Job Specifications

We’re seeking a Quality Engineer to join a leading Medical Device company in Cambridgeshire. The role focuses on providing design control and risk management expertise across medical device and combination product development programmes.

Key Responsibilities

Lead design control and risk management activities supporting development, clinical, and commercial programmes.
Ensure compliance with internal and external quality and regulatory standards.
Collaborate with external design and manufacturing partners to support risk management and design verification.
Contribute to human factors engineering and usability assessments.
Support regulatory submissions, audits, and investigations related to device design and manufacturing.

About You

Degree in a relevant science or engineering discipline (BSc/MSc/PhD).
Experience in combination product or medical device development.
Strong knowledge of ISO 13485, ISO 14971, 21 CFR 820/4, and EU MDR.
Familiarity with EN 62366, EN 60601, and EN 62304.
Detail-oriented, self-motivated, and able to manage multiple priorities.
Excellent communication and cross-functional collaboration skills.

About the Company

We are BioTalent, the life sciences recruitment specialists with the means to nurture change-makers. Our expert consultants focus on Medical Communications, Healthcare Advertising and public Relations, Market Access, Research and development, Data Science & AI, Clinical, Regulatory, Engineering & CQV, Manufacturing & Operation, Quality, Medical and Drug Safety, and Commercial. We have a global reach, with offices in the UK (London), Switzerland (Zug), and the USA (New York, San Diego, Miami and Boston). We are part of T... Know more