KH
Quality Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
1 month ago
- Risk Management
- CAPA
- GxP
- Regulatory Compliance
1 month ago
- We are seeking a Quality Engineer with experience in the Medical Device industry to support innovative healthcare products while collaborating with R&D, Regulatory, and cross-functional engineering teams.
- The ideal candidate will have strong knowledge of Medical Device Quality Engineering, ISO 13485, ISO 14971, Design Controls, Risk Management, Verification & Validation (V&V), Change Control, CAPA, GxP Compliance, and Product Development Support.
- Support Medical Device Quality Engineering activities.
- Collaborate with R&D, Regulatory, and cross-functional engineering teams.
- Support Design Controls and Risk Management activities.
- Participate in Verification & Validation (V&V) activities.
- Support Change Control and CAPA processes.
- Ensure compliance with GxP requirements.
- Provide Product Development support.
- Bachelor's degree in Engineering or a related field.
- 2+ years of Medical Device Quality Engineering experience.
- Strong knowledge of Design Controls, Risk Management, and Regulatory Compliance.
- Excellent communication and problem-solving skills.
Quality Engineer · Katalyst Healthcares & Life Sciences