Quality Manager Med Device Components
Our client is a manufacturer of various metal-based components, used widely throughout the medical device industry with customers like Medtronic, Stryker, and more. This role is based in the Buffalo Grove area at their facility that primarily works with sheet metal and tubing fabrication as well as some light assembly.
Job Description
Manage the company QMS for quality organizational structure and compliance to ISO13485 and other industry standards. Manage and guide the quality team through root cause analysis activity. Ensure all customer complaints are addressed through non-conformance investigations and corrective actions. Manage risk within the plant and develop control plans. Evaluate and create action plans to meet corporate KPIs and performance metrics. Lead a team of quality engineers, a supervisor, and techs / inspectors. Engage and lead all validation activity (IQ / OQ / PQ).
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.
The Successful Applicant
5+ years of experience in a regulated industry, medical device preferred. Extensive experience in audits pertaining to ISO13485, or at minimum other ISO / IATF standards. Strong knowledge of root cause analysis and corrective actions. Metrology and CMM experience. Experience with metal fabrication. Ability to strongly prioritize tasks within a team. Statistical process control and CPK experience.
What's On Offer
Salary up to $140,000 depending on experience and interviews. Up to a 15% bonus depending on performance. Health / medical / dental / vision coverage. 401k matching plan. 3+ weeks of PTO. Voluntary benefits offered.
Contact : Ed Lieser
Quote job ref : JN-102025-6868774
Quality Manager • Buffalo Grove, IL, US