Process Validation Engineer

Job Title

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