QA Product Surveillance Lead

Leica Microsystems • Logan, UT

132d

About The Position

The QA Product Surveillance Lead will direct the Complaint Handling Unit (CHU), ensuring the timely triage, investigation, and closure of product quality complaints. This critical role supports customer satisfaction, regulatory compliance, and continuous improvement by coordinating cross-functional investigations, analyzing complaint trends, and driving corrective actions. This role will interface directly with customers, produce high-quality documentation, and serve as a Subject Matter Expert during audits and customer visits. This position reports to the Senior Manager, Quality Assurance and is part of the Quality Assurance department located in Logan, Utah and will be an on-site role.

Requirements

• Bachelor's degree or equivalent industry experience (minimum 5 years) in GMP-regulated environments such as medical devices or pharmaceuticals.
• At least 3 years of hands-on experience in post-market surveillance, including complaint handling, investigations, and CAPA.
• Strong knowledge of cGMP, ISO 9001/13485, and core QMS principles.
• Experienced in audit readiness, documentation practices, and driving QMS improvements across cross-functional teams.
• Proven ability to manage competing priorities in fast-paced settings.
• Skilled in technical writing, stakeholder communication, and facilitating collaborative problem-solving with attention to detail and quality.

Responsibilities

• Lead Complaint Handling Unit (CHU): Oversee triage, investigation, and closure of product complaints, ensuring timely resolution and high-quality documentation in compliance with QMS standards.
• Analyze and Report Trends: Perform statistical analysis on failure modes and emerging issues across product lines; provide actionable insights and support root cause investigations and corrective actions.
• Cross-Functional Collaboration & Communication: Partner with Manufacturing, Product Management, and Supplier Quality to drive robust investigations; interface with customers and author technical reports and CAPA documentation.
• Support Audits and Continuous Improvement: Act as Subject Matter Expert during audits and customer visits; contribute to internal audit programs and lead process improvement initiatives aligned with quality and compliance goals.

Benefits

• Comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
• Bonus/incentive pay eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree