Quality Engineer

Ready to make an impact where quality truly matters? DentalEZ in Bay Minette, Alabama, is seeking a hands-on Quality Engineer to support the full lifecycle of our dental medical devices-from design transfer through post-market support. In this role, you'll help ensure our products meet the highest standards of safety, performance, and regulatory compliance.

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  Maintain and improve the Quality Management System (CAPA, NCMR, document control).

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  Lead Root Cause Analysis and corrective actions using data-driven tools (5-Whys, Fishbone, Six Sigma).

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  Support risk management activities (dFMEA, pFMEA) aligned with ISO 14971.

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  Partner with suppliers on qualification, audits, and SCARs.

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  Support compliance with the U.S. Food and Drug Administration, ISO 13485, and Medical Device Single Audit Program (MDSAP).

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  Drive scrap reduction, inspection improvements, and continuous improvement initiatives.

You'll have the authority to stop production when quality or safety is at risk-because quality comes first.

• BS in Engineering or related field.

• 3-5 years of medical device manufacturing experience.

• Working knowledge of ISO 13485, MDSAP, FDA 21 CFR 820, and MDD/MDR.

• Internal Auditor experience required; ASQ CQE or Six Sigma certification preferred.

• Strong analytical, metrology, and problem-solving skills.

• Comfortable in a fast-paced manufacturing environment.