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, and conducting internal audits. They will also act as the lead during regulatory and customer audits for the facility. Responsibilities include reviewing and approving documentation such as Change Control Assessments, QMS Procedures, Validation Protocols and Reports, Product Specifications, Test Methods, Audit Reports, CAPAs, and Nonconformances. The role involves developing, implementing, and monitoring Key Performance Indicators (KPI) to assess the performance of the facility's validation program, highlighting trends, risks, and opportunities for improvement, and driving resolution. The Manager will partner with Operations, Advance 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. Additionally, the role includes recruiting, training, leading, retaining, and mentoring direct reports, identifying and implementing organizational changes, and assisting the Site Quality Leader in developing and implementing departmental goals, objectives, policies, budgets, and plans. The position also requires conducting GMP Training for plant employees to ensure awareness of GMP compliance responsibilities and collaborating 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.
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.
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.

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.