Quality Engineer
Katalyst CRO
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. Job Summary 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. Roles & Responsibilities 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. Education & Experience 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. #J-18808-Ljbffr Katalyst CRO
Vacancy posted 3 days ago
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