In this role, you have the opportunity to work on Philips Global QMS to develop new suppliers and maintain required quality of existing suppliers by making sure the applicable quality standards are maintained at the supplier end.
Your role:
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 & V&V) jointly with R&D, 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 R&D.
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
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.