Senior Manager, Quality - Service

ICU Medical - Salt Lake City, UT

Full-time - Manager

Salt Lake City, UT

Merchant Wholesalers, Durable Goods

About the position

The Senior Manager, Quality - Service is responsible for providing quality assurance leadership within the medical device service operations. This role ensures compliance with regulatory standards and maintains an effective Quality Management System. The incumbent will oversee quality activities, support field service engineering, and collaborate with international teams to optimize processes. Additionally, the position involves problem identification and resolution to protect corporate interests and ensure product quality.

Responsibilities

• Direct, coordinate, and manage all quality activities in service operations to meet corporate and regulatory standards.
• Provide quality support to the US Field Service Engineering Team.
• Collaborate with counterparts in other business functions and service leaders outside the US on process optimization.
• Act as Front Room host during audits and inspections.
• Serve on the Corrective and Preventive Action Review Board and Validation Review Board.
• Coach and nurture direct reports as needed.
• Work on special projects as they arise.

Requirements

• Outstanding track record in Quality as an individual contributor and manager.
• Working knowledge of 21 CFR 820, ISO 13485:2003 and above.
• At least 5 years of real-life experience in audit support with FDA, BSI, NSAI, etc.
• Excellent interpersonal and communication skills with a positive attitude.
• Ability to bring people together and work across multi-functional teams to drive issues to resolution.
• Ability to multi-task and deliver under tight deadlines.
• Ability to analyze and synthesize issues for effective communication to management.

Nice-to-haves

• CQE, CMQ, CQA, SSGB, or auditor certification preferred.
• Experience with Class II medical devices preferred.

Benefits

• Affirmative Action and Equal Opportunity Employer.