Quality Engineer III/Cert ISO-13485
Requirement: Certified Auditor ISO aside from the experiences
- Work on non-conforming (NC) reports (Initiate, Analysis, Investigation, Review and close).
- Work with third party supplier to resolve issues with NC.
- Conduct Internal/Supplier Audits of the facility per ISO-1385 and/or 21CFR820
- Minimum required education and experience: Bachelor's degree or equivalent with 8+ years of experience, master’s degree with 5+ years of experience, Doctoral degree with 3+ years of experience
- This position will require relevant experience working in manufacturing/operations.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Experience with a proven track record of implementing appropriate risk mitigation.
- Certified Internal Audit to ISO-13485.
- Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.