Supplier Quality Engineer

JobDiva, Inc.; Plymouth (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

JobDiva, Inc. is seeking a Manufacturing Quality Engineer to drive supplier quality across critical components. You will apply APQP, supplier qualification, audits, and change notice processes to achieve zero-defect performance with supplier partners.

This cross-functional role collaborates with Product Engineering, Supply Chain, Production, and R&D to validate processes, perform DFMAE and PFMEA, and lead process validation plans with suppliers for 700+ parts.

Qualifications

• Bachelor's degree in engineering (Master's degree a plus).
• 3+ years of manufacturing engineering or product quality experience.
• Experience with IQ/OQ/PQ, APQP, and PFMEA.
• ISO 13485 Lead Auditor certification is a plus.
• Experience with plastics, metals, and electronics components.
• Strong written and interpersonal communication skills.

Responsibilities

• Implement APQP and supplier qualification to drive zero-defect performance.
• Collaborate with Product Engineering, Supply Chain, Production, and Suppliers to enable production flow.
• Conduct Process Validation across Spectrawave IGTD portfolios for consoles and catheter parts.
• Lead DFMAE design for manufacturability and PFMEA activities.
• Perform SCAR investigations and supplier corrective actions.
• Monitor supplier performance and drive continuous improvement via audits.

Education

Bachelor's degree in engineering

ISO 13485 Lead Auditor certification

Job description

Roles and Responsibilities:

• Responsible for achieving a state of high-quality performance at our Supplier partners through the application and practice of Advanced Product Quality Planning 'APQP' , Supplier Qualification (Audit, Quality Agreement/Change Notice Agreement), and continuous monitoring the performance supplier to drive zero defect through Supplier Corrective Actions and notification.
• You will fill a high-profile, cross functional position and play an integral role enabling development and production flow of Philips IGTD's critical supply base.
• You will work in close coordination with Product Engineering, Supply Chain and Production and Suppliers to execute effective, creative and smart supply chain strategies to achieve production goals.
• Perform Process Validation and Verification across Spectrawave IGTD portfolios for Consoles and Catheter parts.
• Collaborate with R&D and Quality Design Assurance in Design for Manufacturability and Part Risk management per DFMAE and PFMEA.
• Perform Process Validation , Verification, Test Method Validation, and assess CTS/CTQ criteria per APQP requirement for +700 parts.
• Support Supplier Qualification including Audit, Quality Agreement and Change Notice Agreement.
• Perform Problem solving in the case of FAI and APQP failure.
• Deep dive Value Stream mapping across process.
• Conducts thorough investigations of defects to determine if they are supplier-caused and implement corrections using the SCAR process.
• Proactively manage, monitor, and troubleshoot supplier-related issues for quality of components, sub-assemblies, and assemblies including monitoring trends and managing Supplier Improvement and Supplier Quality Performance Monitoring.
• Providing Quality oversight of product/process change requests from suppliers (SICRs: Supplier Initiated Chage Requests), ensuring appropriate regulatory review and adequate validation to support requested changes including following our APQP process and leading process validation, as necessary
• Develop and oversee process validation plans, including equipment qualifications, with suppliers and lead continuous improvement projects based on process/product trends, customer complaints, industry standards, and government regulations.

Education and Experience:

• Bachelor's degree engineering (Master Degree is plus).
• 3+ years of engineering experience (Manufacturing Engineer and/or Product Quality is plus).
• In-depth product manufacturing and quality experience in process validation and verification Subject Matter in IQ, OQ, PQ
• SO, 13485 Lead Auditor certified is plus.
• Experienced in plastic, metal, electronics commodities.
• Strong written, oral and interpersonal skills to be able to effectively interface interdepartmentally and complete assignments with accuracy and a high attention to detail