Senior Supervisor - Quality Assurance Engineering

Biomerics LLC; Salt Lake City (UT); Vor Ort; USD 110.000 - 135.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Engineering

CAPA

Root cause analysis

Team leadership

Regulatory knowledge

Ausbildung

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

Jobbeschreibung

Company Overview

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics.? We improve and advance our employees' lives and the lives of the patients who depend on our products.

At Biomerics, we are guided by our core values of integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence. We deeply care about our team members and customers, and our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships. Joining our team means becoming part of a dynamic, innovative, and caring community.

Job Summary

The Senior Supervisor - Quality Assurance Engineering is responsible for leading site-level quality operations and maintaining compliance with the Quality Management System (QMS), applicable regulatory requirements, and customer expectations. This position leads Quality Engineering, oversees CAPA and nonconformance processes, supports audit readiness, monitors quality performance, and partners with Manufacturing, Engineering, Operations, and Regulatory teams to drive continuous improvement and reduce Cost of Poor Quality (CoPQ). Reports to the Director of Quality.

Responsibilities

The Senior Quality Engineering Supervisor leads and develops the site's Quality Engineering team, ensuring effective execution of quality processes and compliance with established quality standards, regulatory requirements, and customer expectations. This role oversees day-to-day quality engineering activities, supports CAPA and nonconformance resolution, monitors quality performance, and partners with Manufacturing, Engineering, and Operations to resolve quality issues and drive continuous improvement. Reports to the Senior Manager, Quality Assurance.

• Supervise, coach, and develop Quality Engineers and other assigned quality personnel. Establish priorities, provide technical guidance, and promote accountability and consistent execution.
• Support the implementation and maintenance of the site's Quality Management System (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 to prevent recurring issues.
• Partner with Manufacturing and Engineering to identify and resolve quality issues, improve process performance, reduce defects, and support manufacturing operations.
• Monitor quality metrics, including First Pass Yield (FPY), Cost of Poor Quality (CoPQ), nonconformance trends, and CAPA performance. Identify improvement opportunities and drive appropriate actions.
• Support customer complaints, quality investigations, RMAs, and corrective actions, ensuring timely and effective resolution.
• Support internal, customer, registrar, and regulatory audits. Assist with audit 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.
• Work closely with Manufacturing, Engineering, Operations, and other functional teams to resolve quality concerns, communicate priorities, and ensure consistent application of quality requirements.

Requirements

• Bachelor's degree in Engineering, Materials Science, Plastics, Quality, or a related technical field preferred; equivalent education and experience may be considered.
• 5-7 years of experience in Quality Engineering, Quality Assurance, or a related role within medical device manufacturing or another regulated industry.
• 2-3 years of supervisory, team leadership, or mentoring experience preferred.
• 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.
• Familiarity with problem-solving methodologies such as 5-Why, Fishbone,