Quality Engineers needed for a leading med device manufacturer in IL. As a Quality Engineer you will be part of a team consisting of Program Management, Operations, and Engineering resources responsible for the daily activities that ensure product has been manufactured to specifications and has been distributed within specifications.
location: BUFFALO GROVE, Illinois
job type: Contract
salary: $38 - 45 per hour
work hours: 8am to 4pm
- Lead process risk assessment (e.g...pFMEA, FTA, etc...) throughout its lifecycle.
- Lead nonconformance, product related CAPA, and customer complaint investigations.
- Lead creation and update of inspection plans.
- Lead Test Method Validation.
- Lead decision making thru application of statistical methods.
- Support update of process and equipment work instructions.
- Support identification and execution of process improvements.
- Be the CFT lead for risk management.
- Provide leadership necessary to execute assigned activities as an individual contributor and facilitator.
- Align with cross-functional business partners to determine appropriate support to complete activities and process improvements.
- Management of assigned activities (themselves and team members) to ensure timely completion.
- Support critical issues and investigations as needed
- 4 years experience working within the Medical device industry
- Demonstrated experience with area of responsibility defined in the summary section of this job description
- Documented 21CFR820, ISO13485 and ISO14971 training.
- Bachelor of Science Degree - Engineering discipline required.
- Preferred - Experience with ERP systems.
- Preferred - ASQ Certified
- Experience level: Experienced
- Minimum 4 years of experience
- Education: Bachelors
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