Quality Engineer
DENTALEZ•Bay Minette, AL
•Hybrid
About The Position
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.
Requirements
- 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.
- Strong analytical, metrology, and problem-solving skills.
- Comfortable in a fast-paced manufacturing environment.
Nice To Haves
- ASQ CQE or Six Sigma certification preferred.
Responsibilities
- Maintain and improve the Quality Management System (CAPA, NCMR, document control).
- Lead Root Cause Analysis and corrective actions using data-driven tools (5-Whys, Fishbone, Six Sigma).
- Support risk management activities (dFMEA, pFMEA) aligned with ISO 14971.
- Partner with suppliers on qualification, audits, and SCARs.
- Support compliance with the U.S. Food and Drug Administration, ISO 13485, and Medical Device Single Audit Program (MDSAP).
- Drive scrap reduction, inspection improvements, and continuous improvement initiatives.
- Have the authority to stop production when quality or safety is at risk.
Benefits
- Competitive compensation
- Health, dental, vision, 401(k) with match, PTO, FSA, life insurance, short- and long-term disability, AD&D, EAP
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
