Senior Supervisor - Quality Assurance Engineering

Biomerics LLC•Salt Lake City, UT

About The Position

The Senior Supervisor - Quality Assurance Engineering leads site-level quality operations and maintains compliance with the Quality Management System (QMS), applicable regulatory requirements, and customer expectations. The role leads and develops the site's Quality Engineering team; oversees quality engineering activities, CAPA and nonconformance processes; supports audit readiness; monitors quality performance; and partners with Manufacturing, Engineering, Operations, Regulatory, and other teams to resolve quality issues, drive continuous improvement, and reduce Cost of Poor Quality (CoPQ). The description gives two different reporting lines: the Job Summary says the position reports to the Director of Quality, while the Responsibilities section says it reports to the Senior Manager, Quality Assurance.

Requirements

5–7 years of experience in Quality Engineering, Quality Assurance, or a related role within medical device manufacturing or another regulated industry.
Working knowledge of ISO 13485, 21 CFR 820, ISO 14971, and applicable FDA quality system requirements.
Experience with CAPA, nonconformance management, root-cause analysis, and quality system processes.
Strong analytical, organizational, communication, and problem-solving skills.
Ability to lead and develop team members while effectively collaborating across functional departments.

Nice To Haves

Bachelor's degree in Engineering, Materials Science, Plastics, Quality, or a related technical field; equivalent education and experience may be considered.
2–3 years of supervisory, team leadership, or mentoring experience.
Familiarity with problem-solving methodologies such as 5-Why, Fishbone, and 8D.
Experience with SPC, Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.

Responsibilities

Supervise, coach, and develop Quality Engineers and other assigned quality personnel; establish priorities, provide technical guidance, and promote accountability and consistent execution.
Support implementation and maintenance of the site's QMS in accordance with ISO 13485, 21 CFR 820, ISO 14971, and applicable regulatory requirements.
Oversee and support nonconformance investigations, root-cause analysis, corrective and preventive actions, and effectiveness reviews.
Partner with Manufacturing and Engineering to resolve quality issues, improve process performance, reduce defects, and support manufacturing operations.
Monitor quality metrics, including First Pass Yield (FPY), CoPQ, nonconformance trends, and CAPA performance; identify improvement opportunities and drive actions.
Support customer complaints, quality investigations, RMAs, and corrective actions to ensure timely and effective resolution.
Support internal, customer, registrar, and regulatory audits, including preparation, responses, and timely closure of findings.
Partner with Supplier Quality and Purchasing to address supplier-related quality issues and corrective actions.
Provide quality engineering support for new product introductions, process development, validations, design transfers, and engineering changes.
Promote structured problem-solving and continuous improvement methodologies to improve product quality, process capability, and operational performance.
Collaborate with Manufacturing, Engineering, Operations, and other functional teams to resolve quality concerns, communicate priorities, and ensure consistent application of quality requirements.