Job Title: Sr. Supplier Quality Engineer
Contract Duration: 12 Months
Location: Bedford, MA 01730
Local candidates to the Bedford MA required.
Pay Rate: 50.00/Hourly
Notes from the manager:

• Major focus in experienced Process Validation, Verification across plastic, metal and electronics along with problem solving for candidates to support +700 parts for part qualification for Spectrawave products.
• The product contains Catheter and Console (System) products. Manufacture engineering, Product Quality, and/or SQE with this hands-on experience in Process Validation, Verification and TMV (Test Method Validation) would be right fit to this role.

In this role you:

• 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 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.

Your role:

• 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 Change 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.

You’re the right fit if:

• Bachelor 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
• Min 20% travel time