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.