At a Glance
- Tasks: Lead quality assurance activities to ensure safe and compliant medical devices.
- Company: Join a globally recognised medical tech organisation transforming patient care.
- Benefits: Competitive salary, flexible working options, and comprehensive benefits package.
- Other info: Collaborative environment with opportunities for professional growth.
- Why this job: Make a real impact on healthcare technology and improve patient outcomes.
- Qualifications: Degree in Engineering or Quality with experience in regulated environments.
The predicted salary is between 70000 - 80000 £ per year.
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
- 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
If you’re passionate about quality, safety, and making a real difference in healthcare technology, we’d love to hear from you.
Senior Quality Assurance Engineer / QA Engineer employer: Bright Purple Resourcing
Blake Group is an exceptional employer located in Edinburgh, offering a dynamic work environment where innovation and quality are at the forefront of their engineering and manufacturing operations. With a strong focus on employee growth and development, they provide opportunities for leadership and strategic influence, making this a rewarding role for those looking to make a significant impact in a thriving business. The company's commitment to a high-performance culture and inclusivity ensures that every team member can contribute to and share in the success of the organisation.
