Position Summary
Under the direction of the Global Infusion System Service Quality Director, the US Service Hub and Field Service Engineering Sr. Quality Manager will have QA decision responsibility to provide QA leadership ensuring the proper systems and controls are compliant in order to maintain an effective Quality Management System within the medical device service operations. The US Service Hub is the center of excellence for Serialized Device Service world-wide, and as such, the incumbent responsibility also includes new process creation or improvement that may affect other Service sites outside the US.
The position requires the incumbent to insure the proper disposition of materials and serviced product. Problem identification and resolution abilities are required in dealing with product issues to protect corporate and other ICU sites regulatory, quality and customer interest.
Essential Duties & Responsibilities
- Responsible for the direction, coordination and management of all quality activities in the service operations area to ensure that products and facilities meet all corporate and regulatory standards including but not limited to service/repair activities, incoming inspection, product release, service audit program, design transfer, process validation, change management and quality data analysis and reporting.
- Provides Quality support to the US Field Service Engineering Team
- Responsible to work with counterparts in other business functions and other Service leaders outside the US on process optimization and harmonization.
- Assume Front Room hosting role during audits and inspections.
- Fulfills functions for the site/region quality organization as: Corrective and Preventive Action Review Board member and Validation Review Board member.
- Coach and nurture direct reports as needed.
- Work on special projects as they arise.
Knowledge, Skills & Qualifications
- Outstanding track record in Quality as an individual contributor and manager
- Working knowledge of 21 CFR 820, IS0 13485:2003 and above
- At least 5 years of real-life experience of audit support in the front/back room with FDA, BSI, NSAI etc.
- Excellent interpersonal and communication (written, verbal) skills, with a "get the job done" positive attitude. This individual will act as an ambassador for Service
- Ability to bring people together and work across multi-functional teams to drive issues to resolution in a timely manner
- Ability to multi-task and deliver under tight deadlines
- Ability to analyze and synthesize issues to be elevated to the next level of management for effective communication
Education And Experience
- Minimum BS required (MS a plus) in S.T.E.M., Life Science from an accredited college or university. Masters/MBA preferred.
- Priority will be given to individuals with CQE, CMQ, CQA, SSGB, auditor certification
- At least 10 years of combined engineering, science and/or quality experience in a FDA regulated or mission critical industry
- Experience with Class II medical devices preferred
- At least 5 years of managerial experience (3 or more direct reports)
- Working knowledge of the QMS work streams, including Service
Minimum Qualifications
- Must be at least 18 years of age
Travel Requirements
- Typically requires travel 10-15% of the time
Physical Requirements And Work Environment
- Some work may be performed in a repair type environment
- Must have high level of hand-eye coordination and manual dexterity to work with electro-mechanical medical devices
- Must be able to sit for extended periods of time.
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Engineering
Primary Location
US-UT-Salt Lake City
Schedule
Full-time
Shift
Day Job
