Quality Engineer - CARY, NC
$89,220–$122,672 year
On-site · Cary, North Carolina, United States
Job Summary
Quality Engineer responsible for shaping the Quality Management System by driving CAPA and Document Management process controls. Act as a key audit lead for internal and supplier audits, own and oversee the CAPA process, lead cross-functional CAPA meetings, coach CAPA Owners and Quality Managers, moderate CAPA Steering Board meetings, and serve as the Customer Services CAPA SME during audits. Proactively manage assigned process changes with attention to user needs and operational impact; design and continuously improve training materials for assigned processes. Travel as needed in a global medical device environment.
Required Qualifications
- A Bachelor’s or Master’s degree in Quality, Engineering, Natural Science or a related discipline is preferred
- Minimum 3 years of experience in Quality Management Systems - 5 to 7 years preferred - within a regulated medical device environment in a global acting company
- Auditor Certification REQUIRED - Lead Auditor certification preferred
- Expert knowledge of applicable standards (e.g., ISO 13485, FDA 21 CFR QMSR) for medical devices
- Travel required as needed
- Experience in the medical device industry and strong communication skills
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