Senior Quality Assurance Engineer

Senior Quality Assurance Engineer
-Remote / Hybrid (UK)

We’re working with an innovative, globally recognised medical technology organisation that is transforming patient care through cutting‑edge monitoring and diagnostic solutions.

They are now looking for a Senior Quality Assurance Engineer to play a critical role in ensuring the safety, compliance, and effectiveness of their products throughout the design and development lifecycle.

• Salary of £70,000 - £80,000
• Flexible UK working options
• Comprehensive benefits package
• Work on life‑impacting technology that directly improves patient outcomes
• Be part of a collaborative, innovation‑driven environment
• Influence product quality at a strategic level, not just process compliance

• This is a high‑impact position where you’ll act as a trusted partner to Engineering and Regulatory teams, ensuring that products are developed in line with global standards and best practices.
• You’ll be at the heart of product development, influencing decisions, identifying risks early, and enabling the delivery of safe and compliant medical devices.

• Leading quality activities across design and development, ensuring compliance with internal processes and regulatory requirements.
• Acting as a key contributor in design reviews, evaluating inputs, outputs, verification and validation activities.
• Supporting and guiding teams on Design Controls, Risk Management, and usability considerations.
• Reviewing and approving engineering changes, ensuring product safety and integrity are maintained.
• Driving risk management activities (including hazard analysis and FMEA) in line with ISO standards.
• Supporting nonconformance investigations and identifying trends to inform product improvements.
• Leading or contributing to CAPA activities, ensuring effective resolution and prevention of issues.
• Conducting internal audits and supporting external regulatory inspections.
• Maintaining and improving Quality Management System (QMS) processes and documentation.

• Degree in Engineering, Quality, or a related discipline.
• Strong experience in quality assurance within medical devices or regulated environments.
• Proven background working with Design Controls and Risk Management.
• Solid understanding of Quality Management Systems (QMS).
• Experience supporting new product development within regulated frameworks.
• Knowledge of software within medical devices (SaMD) is highly desirable.
• Strong communication skills with the ability to influence stakeholders at all levels.
• A proactive, detail‑oriented mindset with a passion for product safety and quality.

If you’re passionate about quality, safety, and making a real difference in healthcare technology, we’d love to hear from you.

Apply now or get in touch for a confidential discussion.

Bright Purple is an equal opportunities employer: we are proud to work with clients who share our values of diversity and inclusion in our industry.