
Product Safety and Compliance Expert
3 days ago
We are seeking an experienced Design Quality Assurance Specialist to join our R&D team.
The successful candidate will be responsible for ensuring the highest standards of quality, safety, and innovation in our products.
Main Responsibilities:
- Lead risk management activities including UFMEA, DFMEA, and PFMEA
- Maintain accurate documentation and ensure design control compliance across all NPD projects
- Perform statistical analysis including DOE, process optimization, and variation resolution
- Implement corrective actions and support biocompatibility testing per ISO 10993
- Validate test methods and measurement systems (Gauge R&R, TMV)
- Cultivate a culture of quality and compliance throughout the product lifecycle
Requirements:
- 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
- Attention to detail, adaptability, and problem-solving skills
- Ability to manage multiple projects in a collaborative team environment
Why Join Our Team:
- Contribute to creating innovative products that improve and save lives
- Work in a culture of innovation, growth, and purpose
- Enjoy opportunities for career development in a fast-moving industry
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