Quality Engineer
Illinois, United States
Job Description
Responsibilities:
- Responsible for ensuring cell processes are correctly base-lined & controlled. Known variability is to be accounted for through selection & frequency of inspection, sampling plans, or implementation of SPC.
- Supports the Material Review Board (MRB) for internal non-conformances and customer returns.
- May lead or verify effectiveness of corrective and preventive actions (CAPAs).
- Supervise and train personnel in the inspection of raw materials, in-process and finished goods by using statistical sampling techniques and precision measuring instruments to check conformance to requirements.
- Responsible to create, implement and improve quality systems and procedures for meeting ISO 13485, FDA and customer quality system requirements.
- Bachelor's degree in engineering or related field.
- Medical device manufacturing industry experience.
- 3+ years of experience with tight tolerance measurement systems in machining applications, blueprint reading, GD&T.
- CAPA and Root Cause Analysis.
- Working knowledge of short-run process control methods, DOE, ISO standards, and FDA quality system regulation.
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