Purpose:

·In this role, you have the opportunity to work for Philips Global QMS to develop new suppliers and maintain the required quality of existing suppliers by making sure the applicable quality standards are maintained at the supplier end.

You are responsible for

·Producing and completing Supplier Quality Engineering Activities and related documentation under direct supervision.

·Assist in Qualification of Parts, identification of supplier processes for CTQ’s, Supplier Process Control plans to ensure product quality; by authorizing, supplied parts meets specifications, and the control limits/tolerances for CTQ parameters are met.

·Assist in qualifying and sustaining sub-processes of supplier including supplier audit.

·Support R&D during product development by providing insights on manufacturability and integration and work as quality gatekeeper for all documentation delivered as part of supplier transfer activity.

·Provide Quality oversight of product/process change requests from suppliers, ensuring appropriate regulatory review and adequate validation to support requested changes. 

·Drive supplier improvement via SQIP (Supplier Quality Improvement Plans)

·Lead Supplier Change Notice process with support from Engineering, Quality Engineering / Assurance, Regulatory, ME, R & D, Clinical, etc.

·Performing data analysis and reporting for Supplier Quality Performance Monitoring, assisting in the development of Quality processes relating to Supplier Quality Control’s. Conduct supplier audits and supplier qualification.

·Experience with CPK, APQP, MSA, FMEA, Process Capability Statistics in relation to Six Sigma, which is essentially process optimization, understands QSIT (Quality System Inspection Technique), serve as a Quality interface to suppliers supporting quality and productivity goals, proactively monitoring, measuring product/process quality, performance trends, and troubleshooting of production/release issues.

·Monitor Supplier Non-Conformances, DPPM, FPY, FDR, LAR, CAPA, SCAR ageing and effectiveness and take appropriate actions to maintain them within acceptable limits.

·Supports Design for Excellence (DfX) collaboration between R&D and Suppliers

·Critical to Quality characteristics flow down to Suppliers, Supports Quality Engineering capability assessments of potential new suppliers.

·Support Supplier improvement and development on APQP.

·Supports with Additions/Changes/Deletion to Approved Supplier List, Analysis of defects for determining if supplier caused and then notify. Part Submission Warrant plans, deliverables, line release and completion.

·Technical deep dive analysis to troubleshoot issues, carry out full root cause analysis and ensure preventive actions to avert the issues.

·Ensure adequate change management process is followed at Philips Tier 1- suppliers end and also at the their tier level suppliers.

You are a part of

·Respironics team and will be responsible for achieving a state of high-quality performance at our supplier partners through the application and practice of Advanced Product Quality Planning (APQP) in NPI and throughout the product lifecycle including sustaining change management. You will have the opportunity to work with a global supplier base, drive supplier quality improvement and optimization on diverse set of geographies.

To succeed in this role, you should have the following skills and experience

·Bachelor’s degree, preferably in Electrical/Electronic Engineering

·Certified in ISO 13485: 2016 and /or 21CFR Part 820-preferreed

·Certified IPC Specialist; has thorough knowledge of SMT process, electronic components, and electrical assemblies. Experience in Both PCBA and plastics is preferred.

·10 years’ experience in establishing and maintaining regulated Supplier Management Systems.

· Proven program management skills and must have handled supplier development projects.

·Exceptional communication skills in both English and Chinese.

·Experience with delivering tools/methods for establishing QMS Quality Manuals and Intra-company Quality Agreements

·Change Management – ability to influence stakeholders in the value and benefit of the new processes.

·Good communication skills written & verbal in English.

·Demonstrated experience in collaborative working environments.

·Experience addressing conflicts, escalation at team level to achieve desired results.

·Demonstrated experience handling deadlines, able to focus on targets.

·Demonstrated experience-driving progress, taking initiative to achieve results.

·Experience understanding of the process approach ‘End-to-End.’

·Experience in leading process improvement methodologies.

·Demonstrated capability in organizational Change Management and stakeholder influencing.

·Excellent Supplier relationship management skills

·Proven record of accomplishment of developing suppliers and components.

·Implementing Lean methodologies at supplier end.