Process Validation Engineer

Job Title
Process Validation Engineer

Job Description

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