Quality Engineer
Quality Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- 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 21CFR820Develop interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
- Conduct investigation bounding documentation review and approval of nonconformances CAPAs and customer complaints.
Escalation of quality issues as appropriate. - Accountability and ownership for material identification material segregation classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
- Analyses/review effectiveness of preventive and corrective actions.
- Review root cause investigation according to an established process.
- It is also understood that an associate may receive special projects outside of this list.
- Minimum required education and experience: Bachelors degree or equivalent with 8 years of experience masters 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.
Employment Type
Full Time
