Our Client, a leading contract manufacture of superior medical devices, is seeking an experienced 1st Shift Quality Engineer for their facility located in St. Charles, IL
This is a Direct Hire position that ensures that the quality related engineering needs of the organization are met. Responsibilities include compliance and risk analysis, process validation, pFEMA’s, IQ, OQ, PQ, and PPQ validation. Position works in collaboration with operations, supply chain, & new product development teams.
Compensation range: $70,000-$90,000
Company offers an excellent benefit package, friendly work environment.
Essential Functions:
- Lead in supporting compliance for medical device manufacturer in ID/Traceability throughout supply chain, well documented and executed Acceptance Activities, Non-conforming material management, Packaging/Labeling control, Production/Process controls, and Process Validation.
- Risk Assessments, project meetings, pilot builds, First Article Inspections, and Post Market Risk Management.
- Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
- Design and execution of pFEMA’s, IQ, OQ, PQ and PPQ validation.
- Corrective and Preventive Action management, facilitation, ownership, and problem resolution.
- Process improvement and support, including Quality System process review and revision.
- Training assistance, including providing training in quality system activities/requirements.
- Internal and external audit coordination and facilitation.
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