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Philips Process Validation Engineer in Pune, India

The STET Quality & Process Engineer is responsible for verification / validation via the APQP-PSW process on supplier related projects. They ensure compliance to regulatory requirements and/or procedures for regulated products/processes. They will also mine CoNQ data (QN, Warranty, Scrap, Obso) to identify opportunities for improvements and then execute on those opportunities.

​What you will do in this role :

  • 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 requirements, IEC 60601-1

  • 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 or Master’s degree in Engineering’ (Mechanical/ Electronics/ Electrical)

Experience & Background

  • Minimum of 8 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

  • Six Sigma (DMAIC) Statistical methods and analysis experience. Experience with Quality tools (MSA, Process Capability and SPC)

  • Experience in QMS- ISO 13485/9001 and FDA requirements, IEC 60601-1

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