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- Location
- Mooresville, NC
- Type
- Full-time
- Department
- Engineering
- Education
- Bachelor
- Source
- PCRecruiter
Description
Apollo Technical has an immediate need for a Quality Engineer in the Mooresville NC area
About the Role
We're looking for an experienced Quality Engineer to own validation, calibration, inspection, and quality management systems at our medical device manufacturing sites. You'll work independently with considerable latitude, driving quality objectives and collaborating across engineering, operations, vendors, and customers.
What You'll Do
- Lead machine/process validations and statistical studies; manage gage calibration
- Review design drawings for tolerances and inspectability; interpret technical drawings
- Handle customer complaints and non-conformances, containment, corrective actions, and tracking
- Create and manage Engineering Change Orders (ECOs) and non-conforming parts reports
- Review and communicate internal/external document changes to relevant stakeholders
- Coordinate quality training and maintain supplier quality files
What We're Looking For
- Bachelor's degree in engineering or related field + 5+ years of quality engineering experience
- Advanced knowledge of GD&T and precision measuring tools (calipers, micrometers, CMM, Go/No Go gages)
- Familiarity with ISO 13485 and FDA 21 CFR Part 820
- Proficiency in Microsoft Office, SolidWorks, and ERP software
- Strong blueprint reading skills and ability to work independently with minimal direction
Skills
FDASolidWorksBlueprint ReadingERPGo
