Senior Quality Engineering Lead – Medical Devices

Biomerics; Salt Lake City (UT); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Biomerics is seeking a Senior Supervisor of Quality Assurance Engineering to lead the site’s quality operations and maintain compliance with QMS, ISO 13485, and FDA requirements. The role partners with Manufacturing, Engineering, and Regulatory teams to drive continuous improvement and reduce CoPQ.

Responsibilities include supervising Quality Engineers, overseeing CAPA and nonconformance resolution, and ensuring timely closure of findings while supporting audits and supplier quality actions.

Qualifikationen

• Bachelor's degree in Engineering, Materials Science, Plastics, Quality, or related field.
• 5–7 years in Quality Engineering/QA in medical devices or regulated industry.
• 2–3 years supervisory or mentoring experience preferred.
• Working knowledge of ISO 13485, 21 CFR 820, ISO 14971, and FDA QSRs.
• Experience with CAPA, nonconformance management, root-cause analysis, and QMS processes.
• Familiarity with 5-Why, Fishbone, and 8D problem-solving.
• Experience with SPC, Lean, Six Sigma or similar CI methods.

Aufgaben

• Lead site Quality Engineering team and ensure compliant quality processes.
• Oversee CAPA and nonconformance investigations and root-cause analysis.
• Monitor quality performance metrics and drive continuous improvement.
• Collaborate with Manufacturing, Engineering, Operations and Regulatory teams.
• Support audits and maintain readiness for internal, customer and regulatory audits.
• Provide QA support for new product introductions and process changes.

Kenntnisse

Quality engineering

Regulatory knowledge

CAPA investigations

Root-cause analysis

Leadership

Problem solving

Analytical thinking

Ausbildung

Bachelor's degree in Engineering

Tools

CAPA system

SPC

Jobbeschreibung

Biomerics is seeking a Senior Supervisor of Quality Assurance Engineering to lead the site’s quality operations and maintain compliance with QMS, ISO 13485, and FDA requirements. The role partners with Manufacturing, Engineering, and Regulatory teams to drive continuous improvement and reduce CoPQ.

Responsibilities include supervising Quality Engineers, overseeing CAPA and nonconformance resolution, and ensuring timely closure of findings while supporting audits and supplier quality actions.