Manager, Engineering - Quality

About the Role

This role is for a Manager, Quality Engineering, based in Salt Lake City, UT. The position involves hybrid work with less than 25% domestic and international travel required per year. The successful candidate will work 40 hours per week and must have the legal right to work in the U.S.

Responsibilities

• Provide management and development to Quality Engineers responsible for conducting process validations and assessing 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 the Quality Organization as a core team member on business teams and project reviews to assess quality strategy.
• Conduct internal audits and act as the lead during regulatory and customer audits for the facility.
• Review and approve documentation, including Change Control Assessments, QMS Procedures, Validation Protocols and Reports, Product Specifications, Test Methods, Audit Reports, CAPAs, and Nonconformances.
• Develop, implement, and monitor Key Performance Indicators (KPIs) to assess the performance of the validation program for the facility.
• Highlight trends, risks, and opportunities for improvement and drive resolution.
• Partner with Operations, Advanced Manufacturing Engineering (AME), Supply Chain, Maintenance, Engineering, and other Quality Functions on projects to improve company revenue, process and product quality, manufacturing efficiencies, reduce supply risk, or address compliance risk.
• Recruit, train, lead, retain, and mentor direct reports, and identify and implement changes to the organization structure to better support the manufacturing site.
• Assist the Site Quality Leader in developing, recommending, and implementing section and departmental goals, objectives, policies, budgets, and plans for the effective utilization of Quality Organization resources.
• Conduct GMP Training for plant employees to ensure awareness of GMP compliance responsibilities.
• Work collaboratively with other functions within the organization to identify and prioritize tasks required to achieve business goals associated with projects.

Qualifications

• 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.
• Alternatively, 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

• Expertise/knowledge in quality engineering and quality management principles.
• Experience with failure analysis (pFMEA), test method validation, and understanding of engineering tolerances.
• Knowledge of manufacturing operations within a controlled environment and quality system practices.
• Demonstrated regulatory audit-facing experience and training/experience with ISO13485.
• Proficiency in Minitab statistical software.
• Working knowledge of parts drawing interpretation, Critical Quality Attributes (CQA), Acceptance Sampling, Capability Analysis, and Cause and Effect Analysis.
• Experience writing, reviewing, and/or approving quality documents.

Pay

$147,638 per year

Job Location: ICU Medical, Inc., 4455 Atherton Drive, Salt Lake City, UT 84123

Contact: To apply, send resume to humanresources@icumed.com. Reference JOB CODE: UT0117AG when applying.