Process Validation Remediation Supplier Engineer

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 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 products/parts/services procured from suppliers throughout the product 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, BE, BTech, ME, MTech (Mechanical, Electrical, E&TC)

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