Manager, Engineering - Quality

ICU Medical•Salt Lake City, UT

5d•Hybrid

About The Position

This position provides 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. The role involves providing influential peer and managerial leadership to drive proactive quality improvements to QMS processes and continuous improvement activities to ensure problems are prevented and issues resolved efficiently and economically. The Manager will represent the Quality Organization as a core team member on business teams and projects, assessing quality strategy. Responsibilities include conducting internal audits and leading regulatory and customer audits for the facility. The role requires reviewing and approving documentation such as Change Control Assessments, QMS Procedures, Validation Protocols and Reports, Product Specifications, Test Methods, Audit Reports, CAPAs, and Nonconformances. Additionally, the position involves developing, implementing, and monitoring Key Performance Indicators (KPI) for the validation program, highlighting trends, risks, and opportunities for improvement, and driving resolution. Collaboration with Operations, Advance Manufacturing Engineering (AME), Supply Chain, Maintenance, Engineering, and other Quality Functions is expected to improve company revenue, process and product quality, manufacturing efficiencies, reduce supply risk, or address compliance risk. The role includes recruiting, training, leading, retaining, and mentoring direct reports, and identifying/implementing changes to the organizational structure. The Manager will assist the Site Quality Leader in developing and implementing section and departmental goals, objectives, policies, budgets, and plans for effective resource utilization. Conducting GMP Training for plant employees to ensure awareness of GMP compliance responsibilities is also required. This position requires collaborative work with other functions to identify and prioritize tasks for achieving business goals. Hybrid work is permitted, with reporting to the Salt Lake City, UT office when not working from home. Less than 25% domestic and international travel is required annually.

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.
OR 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.
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 a controlled environment and quality system practices.
Demonstrated regulatory audit facing experience.
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.

Responsibilities

Provide management and development to Quality Engineers responsible for process validations and change assessments 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 teams and projects 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 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.
Highlight trends, risks and opportunities for improvement and drive resolution.
Partner with Operations, Advance Manufacturing Engineering (AME), Supply Chain, Maintenance, Engineering and other Quality Functions 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.
Identify and implement changes to existing 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 defining the effective utilization of the Quality Organization resources.
Conduct GMP Training for plant employees to assure employee awareness of their responsibility to GMP compliance.
Work collaboratively with other functions within the organization to identify and prioritize tasks required to achieve business goals associated with projects.