Senior Quality Assurance Engineering Lead

Biomerics LLC; Salt Lake City (UT); On-site; USD 110,000 - 135,000; Full time

Job summary

Biomerics LLC seeks a Senior Supervisor - Quality Assurance Engineering to lead the site’s quality engineering team and uphold the Quality Management System (QMS) in line with regulatory and customer expectations.

You will oversee CAPA and nonconformance processes, monitor quality performance, and drive continuous improvement across Manufacturing, Engineering, Operations, and Regulatory teams to reduce defects and improve product quality.

Qualifications

• Bachelor's degree in Engineering, Materials Science, Plastics, Quality, or related field.
• 5–7 years in Quality Engineering/QA in medical device manufacturing or regulated industry.
• 2–3 years of supervisory/leadership experience.
• Knowledge of ISO 13485, 21 CFR 820, ISO 14971.

Responsibilities

• Lead site-level quality engineering team and ensure QMS compliance.
• Oversee CAPA and nonconformance investigations and actions.
• Monitor FPY, CoPQ, trends, and CAPA performance.
• Support audits and audit responses; ensure timely closure.
• Partner with Manufacturing, Engineering, and Operations to resolve quality issues.

Skills

Quality Engineering

CAPA

Root cause analysis

Team leadership

Regulatory knowledge

Education

Bachelor's degree in Engineering, Materials Science, Plastics, Quality, or related field

Job description

Biomerics LLC seeks a Senior Supervisor - Quality Assurance Engineering to lead the site’s quality engineering team and uphold the Quality Management System (QMS) in line with regulatory and customer expectations.

You will oversee CAPA and nonconformance processes, monitor quality performance, and drive continuous improvement across Manufacturing, Engineering, Operations, and Regulatory teams to reduce defects and improve product quality.