Quality Engineer, Medical Devices — Flexible Schedule & Remote Day

dentalezinc; Bay Minette (AL); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits

Advancement opportunities

Flexible schedule

Job summary

DentalEZ in Bay Minette, Alabama seeks a hands-on Quality Engineer to support the full lifecycle of dental medical devices—from design transfer through post-market support.

You will ensure products meet safety, performance, and regulatory standards while leading root cause analyses and driving continuous improvement initiatives.

This role offers competitive compensation and comprehensive benefits as part of a collaborative team.

Qualifications

• BS in Engineering or related field required.
• 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.

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. FDA, ISO 13485, and MDSAP.
• Drive scrap reduction, inspection improvements, and continuous improvement initiatives.

Skills

Analytical skills

Problem-solving

Metrology

Education

BS in Engineering or related field

Tools

ISO 13485

MDSAP

FDA 21 CFR 820

MDD/MDR

Job description

DentalEZ in Bay Minette, Alabama seeks a hands-on Quality Engineer to support the full lifecycle of dental medical devices—from design transfer through post-market support.

You will ensure products meet safety, performance, and regulatory standards while leading root cause analyses and driving continuous improvement initiatives.

This role offers competitive compensation and comprehensive benefits as part of a collaborative team.