Our client is a medical device manufacturer located in the near north suburbs of Chicago. With over 15 locations throughout the US and over 5000 employees, they have continued to grow with new product lines and serve major customers like Medtronic, Sktyker and more. They seek a Quality Manager to join and lead their team!
Lead all regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. Leads and implements various product and process improvement methodologies. Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc. Leads in the completion and maintenance of risk analysis. Leads generation and completion of protocols and reports for test method validations. Interfaces with cross-functional leadership to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable. Oversee all CAPA activity - interface with customer leadership as necessary. Lead supplier quality initiatives, communicating directly with their key stakeholders.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
5+ years of Leadership experience in a regulated manufacturing environment, medical preferred. Bachelors degree required, technical/engineering preferred. Strong knowledge of Root Cause Analysis and all associated problem solving methodologies. Ability to drive Statistical Process Control activity (CPK). Extensive experience with dFMEA, Control Plans, and Validations (IQ/OQ/PQ). Metrology experience. Must have experience with metal fabrication/machining in a manufacturing setting. Ability to lead and develop a team of engineers, owning performance metrics.
Base Salary: $120,000-$140,000 depending on experience and interviews. 15% bonus plan. Health/Medical/Dental/Vision Insurance plans offered - BCBS. Voluntary benefits offered - Life, Disability, pet, elder care, etc. 401k match up to 6%. PTO starting out at just over 3 weeks. More.
Contact: Ed Lieser
Quote job ref: JN-122025-6900408
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