Location: This position will be on-site full-time in St. Charles, IL. The position holder will need to be within commuting distance (within 45 min).
Quality Engineer Summary:This position 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, CAPA and etc. Position works in collaboration with operations, supply chain, new product development teams.
Quality Engineer Duties and Responsibilities:- 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, 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
- Performs all other duties as needed.
Quality Engineer Qualification Requirements:- A Bachelor's degree in science, engineering or equivalent
- 3-7 year's relevant experience
- At least 3 years' experience in medical device manufacturing
- Strong knowledge of Quality Systems policies and regulations (ISO 13485 and FDA Part 820) with a strong background in medical device quality assurance and processes
- Experience conducting supplier audits and writing supplier contracts
- Familiarity with statistical analysis
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