Manager, Engineering - Quality

RXinsider LTD.; Salt Lake City, Northern (UT, KY); Hybrid; USD 133,000 - 162,000; Full time

Job summary

ICU Medical, Inc. in Salt Lake City, UT is seeking a Manager, Quality Engineering to lead a team of Quality Engineers responsible for process validations, change control, and QMS improvements across molding, assembly, testing and laboratory equipment.

The role requires GMP/ISO13485 expertise, audit leadership, KPI development, and cross‑functional collaboration with Operations, AME, Supply Chain and other Quality functions.

Qualifications

• Bachelor’s degree plus 4 years in Quality Eng or related field.
• Master’s degree plus 3 years in Quality Eng or related field (if applicable).
• Experience with GMP/ISO13485 and audit leadership.

Responsibilities

• Lead Quality Engineers in process validations and changes.
• Drive continuous improvement of QMS processes and KPI monitoring.
• Prepare for and lead regulatory and customer audits.

Skills

Quality engineering

Failure analysis

Validation

ISO13485

Minitab

Statistics

Documentation

Education

Bachelor’s degree in Biomedical/Industrial/Mechanical Engineering

Master’s degree in Biomedical/Industrial/Mechanical Engineering (optional)

Tools

Minitab

Job description

Job Description

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.

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.