Title: Supplier Quality Enginee
r
Location: Lincolnshire, Illinois
For this position, sponsorship would not be available now or in the future.Responsibilities:- Lead overall quality improvement of Supplier Quality system activities, processes and integrating systems, leading to tangible improvements for the organization.
- Perform required evaluations, visits and auditing of suppliers to FDA, ISO and customer required standards.
- Lead supplier development activities to evaluate current and potential suppliers for their ability to meet customer and regulation expectations.
- Initiate, review and audit Supplier Corrective Action Reports.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Leadership abilities should be included. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor's degree or 10 years required experience in diagnostics or medical device environment or equivalent experience in the Armed Forces.Bachelor's degree with a specialization in science, engineering or health services PREFERRED.
- ASQ CQA or CQE a plus
- 5-7 years total quality assurance experience in a diagnostics or medical device environment.
- Experienced with cGMP, 21CFR820, ISO (9001, 13485), and Canadian Medical Device Regulations
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