Sr Supplier Quality Engineers - Bedford, MA or Plymouth, MN - Onsite

 Up to 20% travel to various sites in the US

Experience:  6+ years of engineering experience

Note:  Manager prefers candidates based in Bedford, MA but Colorado Springs or Plymouth, MN are also options

Job description:

* Responsible for achieving performance improvements with Suppliers through 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.
* High-profile, cross functional position playing an integral role enabling development and production flow of client's critical supply base.
* Work with Product Engineering, Supply Chain and Production and Suppliers to execute effective, creative and smart supply chain strategies to achieve production goals. 
Duties: 
• 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. 

Education/Skills Rerquirements: 
• Bachelor Degree engineering (Master Degree is plus) and 6+ 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 Expert in IQ, OQ, PQ
* SO 13485 Lead Auditor certified is plus. 
* Experienced in plastic , metal, electronics commodities.

 Manoj Prajapati | Non-IT Recruiter