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Supplier Quality Engineer

1 month ago

San Diego, United States MILLENNIUMSOFT Full time

Position: Supplier Quality Engineer

Location: San Diego, CA

Duration: 6+ Months Contract - Temp to FTE Possible

Total Hours/week: 40.00

1st Shift

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

Responsibilities:
• Supports supplier qualification/approval process by assessing supplier QMS as well as manufacturing and technology capabilities through onsite and virtual audit activities
• Supports design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions
• Works with suppliers to establish and maintain robust/rigorous measurement methodologies
• Partners with suppliers to establish and maintain controlled manufacturing processes
• Facilitates root cause analysis and corrective actions for supplier quality issues (SCARs)
• Drives supplier validation activities using Advanced Product Quality Planning (APQP)
• Drives supplier Production Part Approval Process (PPAP) activities
• Reports supplier quality trends, performance, and other information to leadership
• Travel up to 25% may be required

Qualification:
• Bachelor's degree in an engineering discipline is required
• A minimum of 3 years’ experience in a Supplier Quality engineering role is required
• Prior experience within a regulated industry (e.g. medical device, Pharma ) is required
• ISO 13485 Lead Auditor certification is required
• Demonstrated knowledge of the Quality Engineering body of knowledge is required
• Demonstrable good communication and strong writing skills are required
• Familiarity with PCB, PCBA, and electro-mechanical assemblies is a plus.
• ASQ certifications are a plus
• Working knowledge of DMAIC\Six Sigma and problem-solving methodologies is a plus.
• Candidate must be able to work autonomously and independently

Keywords: supplier qualification, manufacturing, Supports design, Supplier Quality, regulated, medical device, Pharma, ISO, PCBA, Six Sigma, PPAP