Quality Manager, Service

Job Description

Position Summary

Under the direction of the Global Infusion System Service Quality Director, the US Service Hub and Field Service Engineering 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, and as such, the incumbent's responsibility also includes new process creation or improvement that may affect other Service sites outside the US.

The position requires the incumbent to ensure 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 interests.

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 for working with counterparts in other business functions and other Service leaders outside the US on process optimization and harmonization.
• Assume Front Room role during audits and inspections.
• Fulfills functions for the site/region quality organization as a 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, ISO 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 (MS a plus) in S.T.E.M., Life Science from an accredited college or university.
• CQE, CMQ, CQA, SSGB, auditor certification preferred.
• At least 8 years of combined engineering, science and/or quality experience in an FDA regulated or mission critical industry.
• Experience with Class II medical devices preferred.
• 2-4 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.

About Us

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:

ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

OFCCP Equal Opportunity Posters

• "Know Your Rights" Poster
• Pay Transparency Nondiscrimination Provision

ICU Medical CCPA Notice to Job Applicants