What are the responsibilities and job description for the Medical Device Quality Engineer position at Grove Technical Resources, INC?
Position : Medical Device Quality Engineer (CAPA and Remediation experience)
Location : Princeton, NJ (Onsite)
Type : W2 contract
Please apply only if you are a U.S. Citizen
Responsibilities :
Lead and support CAPA activities, including root cause analysis and corrective actions.
Drive quality system remediation initiatives to ensure regulatory compliance.
Collaborate with cross-functional teams to address audit findings and non-conformance issues.
Review and enhance documentation in compliance with FDA, ISO 13485, and other regulatory standards.
Support risk management activities and ensure effective quality controls.
Qualifications :
Bachelor's degree in Engineering, Medical Devices, Life Sciences, or related field.
5 years of experience in medical device quality engineering.
Proven expertise in CAPA processes and quality system remediation.
Strong knowledge of FDA regulations and ISO 13485.
Excellent analytical and problem-solving skills.