Procurement Supplier Engineer BP

Job Description

As part of global PV remediation triggered from Suzhou FDA warning letter, IGTS need to complete Process validation remediation program for (BEST, Suzhou Pune) Suppliers (across regions) involved : ~220 Nos, Parts impacted: ~ 6600 It is also our intend to utilize this effort to improve design and supplier processes, wherever possible in order to build robust supply chain Define remediation program scope for NPI and existing production parts. Evaluate implementation priority by assessing complaints, special processes other key design parameters Define project plan for all parts per supplier based on risks assessment and identified priority Assess design impact by reviewing SRPQP and accordingly work on design development activities (CTQ/CTS, DMR VV) jointly with RD, DQA and PIE teams Complete IQ-OQ-PQ processes validation as per ISO13485, FDA21CFR guidelines through supplier on site assessment and qualification Complete APQP activities including PSW, Statistical process controls, line readiness etc Job Description Summary Responsible for achieving a state of high-quality performance at our Supplier partners through the application and practice of Advanced Product Quality Planning APQP during the industrialization of Philips products/parts within the New Product Introduction NPI process through process Validation, review critical characteristics of part specification and DFMAT. Supports Technical Capability Assessments as part of Supplier Selection. Lead and Supports the Approved Supplier List and pursuing continuous quality improvement through the application of Quality Engineering practices on Philips products/parts/services procured from suppliers throughout the prodct lifecycle including sustaining change management Job Description Lead technical capability assessment, technology reviews and sourcing board files. Lead LRP and APQP Level 4, Process Validation. Drive APQP plan development, execution, monitoring and control Strong Understanding in Cp, Cpk and MSA. Deeper understanding of design within individual technical field- Plastics, PCBA, etc to drive DFMAT at suppliers. Lead and challenge Critical to Quality characteristics flow down to Suppliers and communicate feedback to RD. Lead Analysis of defects for deciding if supplier caused and then notified for NCRs and IIA. Lead problem solving for SQNs, SCAR and Quality Improvement plan. Lead, own SICRs at site levels, and manage SICRs priorities with stakeholders. SME, can be a trainer. Able to demonstrate and solve complex problems using problem solving tools. Strong control over DFMEA to PFMEA linkage and process controls. Lead Supplier improvement and communicate the challenges and resolutions to stakeholders. Lead factory support per site for supplier related issues. Key Performance Indicators: Supplier Product Quality targets met at launch - NPI (PDLM)/MLD projects. Meet the requirement for Process Validation and PSW Deliverables on time to target milestones. Execute SICRs in timely manner to avoid any operational line down. Required Competencies: Stakeholder Management Effective Communication Collaboration/Teamwork Conflict resolution and negotiation Hands on Design and technical experience. Project Management Process Validation and Verification ISO 13485/9001 and FDA requirement Problem Solving skills through 6 sigma/Leon/Other strategic approach. Knowledge of Statistical methods and analysis. Experience with Quality tools (MSA, Process Capability and SPC). Education Training Bachelor s degree in engineering science, or equivalent experience Experience Background Minimum of 10 years of related engineering experience (medical device or regulated industry preferred). Wide-ranging experience within an engineering function. Well versed in Quality Engineering and Continuous Improvement techniques. Direct working relationships with suppliers Participated in several NPIs from start to finish. Direct shop-floor production engineering sustaining experience

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