Quality Engineer

Dentalez • Bay Minette, AL

19h • Hybrid

About The Position

Quality Engineer Dental Medical Device Manufacturing | DentalEZ 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. What You'll Do 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. You'll have the authority to stop production when quality or safety is at risk-because quality comes first. What You Bring 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. What's in It for You Competitive compensation Comprehensive benefits – Health, dental, vision, 401(k) with match, PTO, FSA, life insurance, short- and long-term disability, AD&D, EAP, and more Advancement opportunities across the organization Flexible schedule – Monday–Friday, 8:00 am–5:00 pm, with one remote day per week (typically Friday) and additional remote flexibility when needed Collaborative culture where every team member is valued and empowered to make real change Why You'll Love It Here High-impact role with visibility across Engineering, Operations, and Leadership A company with more than 100 years of trusted industry presence Products that directly improve dental practices and patient experiences A team-oriented environment where your ideas are heard and acted upon About DentalEZ For over 100 years, DentalEZ has produced innovative dental operatory systems including cabinetry, patient chairs, delivery units, and 100% water-free vacuum systems. Our equipment is designed to create ergonomic, hygienic, and efficient dental environments trusted by professionals worldwide. If you're a proactive, solutions-driven Quality Engineer ready to build quality into every process-we'd love to connect. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, disability or protected veteran status or any other status protected by law. If you are interested in applying for employment with DentalEZ and need assistance or an accommodation to use our website, please contact us by email or phone. Email: [email protected] Phone: [phone]

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

Benefits

• Competitive compensation
• Comprehensive benefits – Health, dental, vision, 401(k) with match, PTO, FSA, life insurance, short- and long-term disability, AD&D, EAP, and more
• Advancement opportunities across the organization
• Flexible schedule – Monday–Friday, 8:00 am–5:00 pm, with one remote day per week (typically Friday) and additional remote flexibility when needed
• Collaborative culture where every team member is valued and empowered to make real change
• High-impact role with visibility across Engineering, Operations, and Leadership
• A company with more than 100 years of trusted industry presence
• Products that directly improve dental practices and patient experiences
• A team-oriented environment where your ideas are heard and acted upon

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level