Supplier Quality Engineer at Pacer Group in Irvine, California

Job Description:

Job Description:

The candidate will be responsible for supplier quality audits, vendor management, and maintaining supplier quality metrics. Will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success. This role will work in close partnership with Quality, R&D, Operations, Sourcing, and RA.

Responsibilities:

• 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

Required Qualifications:

• Bachelor's degree in Engineering or Scientific field

Preferred Qualifications:

• Engineering degree
• Experience with supplier quality engineering activities, including external supplier vendor audits
• 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
• Experience with class II and class III medical devices
• Medical device, pharma, or biotech industry experience
• Demonstrated ability to apply statistical quality engineering tools in a supplier environment
• Working knowledge of International and Domestic FDA regulations
• Effective communication and conflict resolution skills
• 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

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