Senior Quality Assurance Engineer -Remote / Hybrid (UK)
Were 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
* 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
The Opportunity
* This is a high-impact position where youll act as a trusted partner to Engineering and Regulatory teams, ensuring that products are developed in line with global standards and best practices.
* Youll be at the heart of product development, influencing decisions, identifying risks early, and enabling the delivery of safe and compliant medical devices.
What Youll Be Doing
* 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
What Were Looking For
* 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
Interested? If youre passionate about quality, safety, and making a real difference in healthcare technology, wed 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.
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