Senior Quality Engineer
2 days ago
Edinburgh
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.