Are you ready to make a real impact? We’re seeking a Quality Specialist to ensure that next-generation medical technologies meet the highest standards of safety, compliance, and innovation.
About the Role
As a Quality Specialist 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!
Quality Specialist, Quality Engineer, Design Quality Engineer, Quality Assurance Engineer
