Supplier Quality Engineer
Duration - 1 Year, Contract, W-2
Location - Irvine, CA
Pay - $35- $41.03 an hour
Duties:
* Responsible for supplier quality audits , vendor management , and maintaining supplier quality metrics .
* Provide receiving inspection floor support, perform test method development , run supplier meetings , and design/risk document creation .
* Work in close partnership with Quality, R&D, Operations, Sourcing, and RA.
* Audit, monitor, evaluate, report and improve supplier quality system performance and provide technical support to suppliers
* Perform supplier evaluations including on-site audits to assess supplier capabilities, determine approval status, and verify corrective action
* Collect and add supplier information required for the Approved Supplier List
* Conduct component and product quality testing for purposes of supplier and component qualification and improvement
* Identify and implement statistical engineering tools and techniques to evaluate supplier process capability and technical performance
* Evaluate supplier quality systems , strategies, and regulatory compliance via vendor audits
* Collect and analyze quality metrics relating to Supplier Quality
* Identify and define correction actions and follow-up to ensure completeness and effectiveness
* Communicate supplier quality risks to upper management while suggesting improvements and cost savings where possible
Qualifications:
* Bachelor's degree in Engineering or Scientific field & Medical device , pharma, or biotech industry experience
* Experience with supplier quality engineering activities including external supplier vendor audits for class II and class III medical devices
* Previous experience in design/prototyping using Solidworks/Creo (CAD software) drafting experience required
* Statistical analysis ( Minitab ), Excel macro coding , Power BI skills highly preferred
* Effective problem-solving techniques (i.e. Root Cause Analysis, FMEA process, Gage R&R, Validation activities, etc.)
* Conduct effective root cause investigations ; assessment of corrective action strategies ; and effectiveness as applied to NCRs and SCARs
* Demonstrated ability to apply statistical quality engineering tools in a supplier environment
* Working knowledge of International and Domestic FDA regulations
* Thorough understanding of Risk Management principles
* Strong communication and organizational skills to effectively manage and get results with external suppliers
* Six Sigma Black Belt/LEAN Manufacturing experience
* ASQ Certified Quality Engineer or ASQ/BSI Certified Quality Auditor
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
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