Process V&V Engineer
jobdivaBedford (MA)
About the role
Summary:
Achieve 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 IGTDs 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.
Roles & Responsibilities:
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.
Requirements:
Bachelor Degree engineering (Master Degree is plus) with a preference in Mech Engr or Biomedical Engr
10+ years of relatable engineering experience (Manufacturing Engineer and/or Product Quality that works in V & V).
5+ yrs of experience in a leadership role resolving non-conformance and Mnfg Process V & V.
Subject Matter expert 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.
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