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 includingmonitoring 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
Numbers & Facts
Location
Bedford, MA
Skills
Advanced Product Quality Planning (APQP)unmatched
Auditingunmatched
Catheterizationunmatched
Change Requests/Ordersunmatched
Continuous Improvementunmatched
Corrective Actionunmatched
Cross-Functionalunmatched
Detail Orientedunmatched
Electronicsunmatched
Engineeringunmatched
Government Regulationsunmatched
Identify Issuesunmatched
Industry Standardsunmatched
Interpersonal Skillsunmatched
Manufacturingunmatched
Manufacturing Designunmatched
Manufacturing Engineeringunmatched
Performance Analysisunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Process Failure Mode and Effects Analysis (PFMEA)unmatched
Process Qualityunmatched
Process Validationunmatched
Product Engineeringunmatched
Quality Assuranceunmatched
Quality Assurance Methodologyunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Quality Monitoringunmatched
Regulationsunmatched
Research & Development (R&D)unmatched
Risk Managementunmatched
Supply Chainunmatched
Validation Planunmatched
Validation Testingunmatched
Value Stream Mappingunmatched
Vendor/Supplier Evaluationunmatched
Vendor/Supplier Managementunmatched
Writing Skillsunmatched
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