This is a high-impact Senior Quality Engineering role at an ambitious MedTech organisation that is transforming patient care through cutting-edge solutions.
They are now looking for a Senior Quality 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 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.
What You’ll 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 We’re 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 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.
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