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.
What Is In It For You
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Salary of £70,000 - £80,000
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Flexible UK working options
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Comprehensive benefits package
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Work on life-impacting technology that directly improves patient outcomes
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Be part of a collaborative, innovation-driven environment
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Influence product quality at a strategic level, not just process compliance
The Opportunity
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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.
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You’ll be at the heart of product development, influencing decisions, identifying risks early, and enabling the delivery of safe and compliant medical devices.
What You’ll Be Doing
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Leading quality activities across design and development, ensuring compliance with internal processes and regulatory requirements
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Acting as a key contributor in design reviews, evaluating inputs, outputs, verification and validation activities
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Supporting and guiding teams on Design Controls, Risk Management, and usability considerations
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Reviewing and approving engineering changes, ensuring product safety and integrity are maintained
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Driving risk management activities (including hazard analysis and FMEA) in line with ISO standards
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Supporting nonconformance investigations and identifying trends to inform product improvements
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Leading or contributing to CAPA activities, ensuring effective resolution and prevention of issues
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Conducting internal audits and supporting external regulatory inspections
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Maintaining and improving Quality Management System (QMS) processes and documentation
What We’re Looking For
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Degree in Engineering, Quality, or a related discipline
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Strong experience in quality assurance within medical devices or regulated environments
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Proven background working with Design Controls and Risk Management
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Solid understanding of Quality Management Systems (QMS)
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Experience supporting new product development within regulated frameworks
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Knowledge of software within medical devices (SaMD) is highly desirable
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Strong communication skills with the ability to influence stakeholders at all levels
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A proactive, detail-oriented mindset with a passion for product safety and quality
Interested?
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.