Nan Winn
Bloomington,IN
Summary
Supplier Quality/Quality Engineering professional with extensive experience across appliances, lighting, aviation, medical devices, pharmaceuticals, and battery systems. Proven expertise in FTZ administration, material and supply chain management, and continuous improvement initiatives. Demonstrated success in supplier audits and management, utilizing lean manufacturing and Six Sigma methodologies to enhance operational efficiency. Committed to driving quality excellence and supporting organizational transformation.
Overview
17
17
years of professional experience
Work History
Engineer
NSWC Crane
Crane, IN
09.2024 - Current
- Performed risk assessment and FMEA reviews with suppliers to identify potential issues before they arise.
- Assessed operations and made key suggestions to implement more cost-effective processes and lean manufacturing principles.
- Conducted a supplier process review to ensure quality controls are in place, and standards were maintained.
- Reviewed supplier documentation and test reports to verify product conformity.
- Facilitated communication between internal stakeholders and external vendors regarding quality requirements.
- Facilitated communication between internal stakeholders and external vendors regarding supply chain quality-related activities.
- Documented all engineering technical activities according to established internal procedures.
Procurement Process Manager
Catalent Biologics
Bloomington, IN
07.2023 - 08.2024
- Evaluated and improved current procurement processes and systems. Improved payment process and reduced late payments to suppliers by 50%.
- Procurement Point of Contact for supplier quality-related issues, to decrease production downtime due to raw material shortages.
- Created monthly metrics guidelines and reports for senior leadership, summarized procurement annual operational performance metrics.
- Improved vendor-managed inventory process. Reduced the number of points of use on site to reduce inventory and increase cash flow.
Supplier Quality Engineer
Cook Medical
Bloomington, IN
12.2021 - 06.2023
- Provided technical support to internal departments regarding supplier selection, qualification and performance evaluation processes.
- Developed and implemented corrective action plans for suppliers who failed to meet the required quality specifications and requirements.
- Conducted root cause analysis and corrective action investigations of non-conforming products.
- Reviewed supplier documentation (process validation, drawing, inspection, test method validation) and test reports to verify process outputs and product conformity.
- Assisted in the selection of new suppliers based on quality, cost and delivery performance criteria.
- Performed risk assessment and FMEA reviews with suppliers to identify potential issues before they arise.
- Coordinated with purchasing team to ensure that all purchased materials met specifications.
- Created internal purchased materials specifications and Incoming Quality Inspection documentations to support production.
- Analyzed non-conforming material data from production processes to determine root cause of product non-conformances.
- Worked with stakeholders to review and approve supplier-initiated changes and associated specification documentation changes.
- Conducted and Led ISO 13485 supplier audits to ensure quality standards were maintained.
- Coordinated with supplier to Implement corrective action plans when necessary as a result of audit, field action or other quality related findings.
- Maintained a database of approved suppliers along with their ratings and audit results for easy reference by other departments.
- Ensured that all necessary documents related to suppliers are up-to-date according to company quality management procedures.
- Served as liaison between company's senior management and suppliers to identify quality issues and drive solutions.
- Provided technical advice and guidance to suppliers to reduce defect rates.
- Investigated customer complaints regarding product quality; developed corrective action plans based on investigation results.
- Created and implemented supplier-own-quality procedure and process.
Training and Development Manager
Cook Medical
Bloomington, IN
06.2019 - 12.2021
- Collaborated with stakeholders to screen potential candidates and assist with co-op interviews and onboarding for the engineering co-op program
- Played a key role in co-op program development and supported to the rest of the engineering organizations (R&D, Manufacturing, and Post-Market)
- Collaborated with other functions to develop and maintain competencies and job descriptions, and the associated training for Cook Inc M&PM Engineering.
- Developed and implemented training programs to meet the needs of a diverse workforce.
- Coordinated with departments to ensure that employees received appropriate on-the-job training.
Supplier Engineer
Cook Medical
Bloomington, IN
11.2016 - 05.2019
- Evaluated supplier changes in accordance with local quality system, 21CFR820.50(b) and ISO 13485 to ensure safe and effective raw material was received to operations in a timely manner.
- Executed project deliverables including: project plans (Supplier Change Project Plan, Design Change Plan), Design Control Traceability Table, Process Validation Plan, Process Capability, design verification test protocols and reports (ISO-10555, ISO-11070, ASTM D3359-09), Product Quality Assessment, feasibility testing, RS, DFMEA, PFMEA.
- Tested prototypes using a variety of test methods (tensile testing and liquid leakage testing..etc).
- Coordinated testing conducted by external labs such as biocompatibility testing, Endotoxin and Bioburden testing and interpret testing results to stakeholders.
- Analyzed data including: equivalency, capability, power and sample size, and two sample tests.
- Collaborated with cross-functional teams throughout the change control process to ensure project completion.
- Documented all engineering activities in PLM according to established procedures.
- Evaluated, documented, and resolved specifications discrepancies for materials provided by external suppliers.
- Mentored full time and co-op employees.
- Developed and created training material for new team members.
- Worked closely with suppliers to ensure raw materials supplier chain is not disrupted.
- Guided engineers (non-supplier engineering), provided input, and approved plans for changes to product/process and quality systems
Business Team Leader/ Material Planner/NPI Leader
GE Appliances
Bloomington, IN
12.2010 - 10.2016
- Led team meetings and ensure all objectives are met on time.
- Developed product schedule and communicated timeline to stakeholders.
- Analyzed material requirements and scheduled production activities accordingly.
- Managed day to day raw material forecasts and demand planning with overseas/domestic suppliers and cultivated supplier relationships.
- Maintained the whole supply chain of production parts including shipping, warehousing and receiving.
- Coordinated with logistics team for efficient transportation of finished goods from warehouses.
- Maintained raw material receiving process and made improvement.
- Evaluated supplier initiated raw material changes.
- Coordinated ship test and approval process.
- Trained new employees on the company's processes and procedures.
- Resolved conflicts between team members, ensuring productivity was maintained.
- Maintained accurate records of employee performance, hours worked and attendance.
- Monitored team performance, providing feedback to individual members as needed.
- Provided guidance and direction to team members when working on complex projects.
- Ensured that all safety protocols were followed at all times in the workplace.
- Evaluated existing systems and processes, recommending changes where appropriate.
- Led Lean events to streamline material delivering and inventory management processes.
Product Quality Engineer
GE Aviation
Cincinnati, OH
07.2008 - 01.2009
- Qualified or disqualified international suppliers according to GE quality standards.
- Evaluated supplier performance against established supplier scorecard; provided feedback to suppliers regarding non-conformance.
- Reviewed engineering drawings, specifications and test results to ensure compliance with the required standards.
- Maintained successful relationships with engineering and sourcing departments.
- Served as a liaison for suppliers, suggested quality and process improvements to improve production efficiency and quality.
- Served as a technical supported for the RFQ process.
Business Team Leader
GE Consumer & Industrial
Bloomington, IN
- Supervised an hourly workforce in an assembly manufacturing plant
- Responsible for safety, quality, and cost
- Led Lean events to eliminate waste and improve the process
- Made an annual 35% increase in productivity through improvements in operation, quality, and safety.
GE Operation Management Leadership Program - Four Rotations within Supply Chain
GE Consumer and Industrial
Various Location in US
- Lean Champion Role (1st Rotation): Utilized Lean tools to improve productivity and eliminate waste in a Lighting manufacturing plant
- Supervisor Role (2nd Rotation): Led approximately 130 hourly employees in production in an automotive light bulb factory
- Facilitated implementation to VPP site under OSHA standards and maintained a zero OSHA recordable safety rate
- New Production Introduction PMQE Role (3rd Rotation): Sustained relationships between new suppliers and internal leadership teams to qualify new parts
- Ensured material availability and assisted with resolving quality and capacity constraints
- Material Planner Role (4th Rotation): Responsible for planning and monitoring parts required to support production in a side-by-side refrigeration plant.
Education
Bachelor of Science - Industrial Engineering
University of Michigan
01.2005
Skills
- Six Sigma Green Belt
- Fluent in Chinese
- APICS and ISO13485 Lead Auditor Certified
- Proficient in PLM and ERP systems
- Read and speak some Japanese
- Complex Problem-Solving
- Team Leadership
- Cross-Functional Team Management
Timeline
Engineer
NSWC Crane
09.2024 - Current
Procurement Process Manager
Catalent Biologics
07.2023 - 08.2024
Supplier Quality Engineer
Cook Medical
12.2021 - 06.2023
Training and Development Manager
Cook Medical
06.2019 - 12.2021
Supplier Engineer
Cook Medical
11.2016 - 05.2019
Business Team Leader/ Material Planner/NPI Leader
GE Appliances
12.2010 - 10.2016
Product Quality Engineer
GE Aviation
07.2008 - 01.2009
Business Team Leader
GE Consumer & Industrial
GE Operation Management Leadership Program - Four Rotations within Supply Chain
GE Consumer and Industrial
Bachelor of Science - Industrial Engineering
University of Michigan
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