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