Are you ready to make a real impact? We’re seeking a Design Quality Engineer to ensure that next-generation medical technologies meet the highest standards of safety, compliance, and innovation.
About the Role
As a Design Quality Engineer, you’ll be at the heart of new product development—driving quality, leading risk management activities, and ensuring compliance with global regulatory standards. You’ll collaborate with R&D, Design, manufacturing and regulatory teams to bring safe, effective, and life-changing products from concept to launch.
What You’ll Do
- Lead risk management activities(UFMEA, DFMEA, PFMEA) and maintain documentation
- Ensure design control compliance across all NPD projects
- Perform statistical analysis(DOE, process optimisation, variation resolution) and initiate corrective actions
- Support biocompatibility testing per ISO 10993
- Contribute to internal and supplier audits
- Validate test methods and measurement systems(Gauge R&R, TMV)
- Champion a culture of quality and compliance throughout the product lifecycle
What We’re Looking For
- Degree in Engineering, Science, or a technical field
- 5+ years’ experience in the medical device or pharmaceutical industry
- Strong knowledge of ISO 13485, ISO 14971, ISO 10993, and relevant CFRs
- Detail-oriented, adaptable, and a natural problem solver
- Ability to manage multiple projects while thriving in a collaborative team environment
Why Apply?
- Be part of creating products that improve and save lives
- Work in a culture of innovation, growth, and purpose
- Enjoy career development opportunities in a fast-moving, global industry with a healthy pipeline of projects
Take the next step in your career and help shape the future of healthcare. Apply today!
Design Quality Engineer, Quality Engineer, Design Quality Engineer, Quality Assurance Engineer
