Manager, Quality Engineering (Job Code: UT0117AG)
Responsibilities
Provide management and development to Quality Engineers responsible to conduct the process validations and assess any changes for Molding, Automated Assembly Equipment, Manual Assembly, Test methods, Testing and Laboratory Equipment. Provide influential peer and managerial leadership to drive proactive quality improvements to QMS processes. Proactively drive continuous improvement activities to ensure problems are prevented and issues resolved efficiently and economically. Represent Quality Organization as a core team member on business team and projects review and to properly assess quality strategy for them. Able to conduct internal audits and to act as the face and lead during regulatory and customer audits for the facility. Review and approve documentation, including but not limited to Change Control Assessments, QMS Procedures, Validations Protocols and Reports, Product Specifications, Test Methods, Audit Reports, CAPAs and Nonconformances. Develop, implement and monitor Key Performance Indicators (KPI) to assess performance of validation program for the facility. Able to highlight trends, risks and opportunities for improvement and to drive resolution. Partner with Operations, Advance Manufacturing Engineering (AME), Supply Chain, Maintenance, Engineering and other Quality Functions to work on projects to improve company revenue, process and product quality improvement, manufacturing efficiencies, reduce supply risk or address compliance risk. Recruit, train, lead, retain and mentor direct reports and able to identify and implement changes to existing organization structure to better support the manufacturing site. Assists the Site Quality Leader in the developing, recommending and implementing of section and departmental goals and objective policies, budgets and plans for defining the effective utilization of the Quality Organization resources. Conducts GMP Training for plant employees to assure employee awareness of their responsibility to GMP compliance. This position is required to work collaboratively with other function within the organization to identify and prioritize tasks required to achieve business goals associated to these projects. *Hybrid work is permitted. When not working from home, must report to Salt Lake City, UT office. *< 25% domestic and international travel required per year.
EDUCATION AND EXPERIENCE REQUIREMENTS:
Bachelor’s degree in Biomedical Engineering, Industrial Engineering, Mechanical Engineering, or closely related science field (or foreign equivalent) plus four (4) years of experience in the job offered or related occupation. In lieu of this, the Employer will accept a Master’s degree in Biomedical Engineering, Industrial Engineering, Mechanical Engineering, or closely related science field (or foreign equivalent) plus three (3) years of experience in the job offered or related occupation.
SPECIAL REQUIREMENTS:
Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be “quantified” by “time.” Required expertise/knowledge includes: Knowledge of the principles of quality engineering and quality management; Experience doing and reviewing failure analysis (pFMEA), test method validation, and understanding of
engineering tolerances; Knowledge of manufacturing operations within controlled environment and quality system practices; Demonstrated regulatory audit facing experience and training/experience with ISO13485; Proficient in Minitab statistical software; Working knowledge of parts drawing interpretation, Critical Quality Attributes (CQA), Acceptance Sampling, Capability Analysis, Cause and Effect Analysis); Experience writing, reviewing and/or approving quality documents.
JOB LOCATION: ICU Medical, Inc.
4455 Atherton Drive, Salt Lake City, UT 84123
40 hours per week / $147,638 per year
If offered employment, must have legal right to work in U.S.
CONTACT: To apply for ICU Medical, Inc.’s Manager, Quality Engineering position please send resume to: [email protected]
Must reference JOB CODE: UT0117AG when applying.
EOE M/F/D/V
It is the policy of ICU Medical, Inc. to afford full equal employment opportunity to qualified employees and applicants, regardless of their race, color, religion, sex, national origin, age, physical or mental handicaps, military or veteran status, sexual preference, or any other protected condition or characteristic in conformity with all applicable federal, state and local laws and regulations.
Skills Required
- Bachelor's degree in Biomedical Engineering, Industrial Engineering, Mechanical Engineering, or a closely related science field, plus four years of related experience
- Alternatively, a master's degree in Biomedical Engineering, Industrial Engineering, Mechanical Engineering, or a closely related science field, plus three years of related experience
- Knowledge of quality engineering and quality management principles
- Experience performing and reviewing failure analysis, including pFMEA
- Experience with test method validation and engineering tolerances
- Knowledge of manufacturing operations in a controlled environment and quality system practices
- Regulatory audit-facing experience
- ISO 13485 training or experience
- Proficiency in Minitab statistical software
- Working knowledge of parts drawing interpretation, Critical Quality Attributes, acceptance sampling, capability analysis, and cause-and-effect analysis
- Experience writing, reviewing, or approving quality documents
- Legal right to work in the United States
ICU Medical Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICU Medical and has not been reviewed or approved by ICU Medical.
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Retirement Support — Retirement offerings include a 401(k) with a company match and mentions of immediate vesting in some cases. Feedback suggests this component is one of the more reliable strengths of the package.
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Leave & Time Off Breadth — Paid time off and holidays are consistently highlighted as stronger elements within the benefits mix. Feedback suggests time-off policies compare favorably relative to other benefit areas.
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Healthcare Strength — Core coverage spans medical, dental, and vision alongside HSA/FSA and life/disability options. Feedback suggests the breadth is comprehensive even if the depth feels average in places.
ICU Medical Insights
What We Do
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables. Since IV therapy is our only business, meeting your IV needs with quality products and consistent supply is our only concern. We are 100% focused on bringing you intuitive, patient-centric IV products and services that provide meaningful clinical differentiation, consistent innovation, and superior value. We design our products to work within your existing workflows to minimize disruption and maximize the time you spend with patients. Together, we help forge the human and emotional connections that enhance clinical experience and are the essence of outstanding quality of care. For more than three decades, we have been dedicated to a singular purpose—improving the safety and efficiency of IV therapy. With the acquisition of Hospira Infusion Systems from Pfizer in 2017, we became the only company to focus exclusively on IV therapy across the continuum of care. 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.
