Senior Quality Assurance Engineer

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.