Selena Lin
San Jose,CA
Summary
Quality Lead Engineer with 10+ years of experience in medical device manufacturing, specializing in quality systems, regulatory compliance, and process validation. Highly experienced in ISO 13485 and FDA-regulated environments, with a strong track record in audit support, customer quality management, and continuous improvement. Demonstrated leadership capability through acting Quality Manager responsibilities, FDA compliance involvement, and direct engagement in internal and external audits.
Overview
9
9
years of professional experience
Work History
Quality Lead Engineer
MOS Plastics Inc.
San Jose, CA
01.2018 - Current
- Promoted from Quality Engineer based on strong performance and contributions
- Serve as backup Quality Manager, ensuring continuity of quality operations and cross-functional leadership
- Reduced RMA rate from 7% to below 1%, significantly improving product quality and customer satisfaction
- Lead end-to-end validation and product launch from development to mass production, including PPAP submission, customer communication, and cross-functional coordination
- Play a key role in all external audits (ISO 13485:2016 and customers), partnering with Quality Management to respond to auditor inquiries and present objective evidence, maintaining zero major ISO findings for 7+ years
- Lead CAPA and root cause investigations, reducing recurring quality issues and improving process stability
- Drive internal audits and continuous improvement initiatives to reduce cost of poor quality and improve operational efficiency
- Coordinate Management Review activities, including quality metrics analysis and executive-level reporting to support strategic decision-making
- Direct supplier quality management, including supplier qualification, performance monitoring, and issue resolution
- Develop and deliver training programs to strengthen team capability and ensure compliance with quality standards
- Leverage data analytics to identify defect trends and proactively prevent quality issues before escalation
Quality Engineer
MOS Plastics Inc.
San Jose, CA
01.2017 - 12.2017
- Managed MRB activities and nonconforming materials
- Handled customer complaints and RMA processes
- Supported CAPA and investigations
- Participated in audits and QMS maintenance
Junior Quality Engineer
Lock-N-Stitch, Inc.
Turlock, CA
- Reduced rejection rate from 17% to 4%
- Reduced inspection time from 1.5h to 0.5h
- Conducted SPC and Gage R&R; analysis
- Developed AQL sampling plans
- Supported ISO 9001 compliance
Education
M.S. - Mechanical Engineering
Stevens Institute of Technology
B.E. - Automotive Engineering
China Agricultural University
Skills
- Certifications: ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), Lean Six Sigma Green Belt
- Quality Systems & Regulatory Compliance (ISO 13485, FDA, audits, QMS)
- Risk Management & Quality Planning (PFMEA, control plans, metrics)
- Leadership & Cross-Functional Coordination (training, decision-making)
- CAPA & Root Cause Analysis (8D, 5 Whys)
- Process Validation (IQ, OQ, PQ, FAI)
Timeline
Quality Lead Engineer
MOS Plastics Inc.
01.2018 - Current
Quality Engineer
MOS Plastics Inc.
01.2017 - 12.2017
Junior Quality Engineer
Lock-N-Stitch, Inc.
B.E. - Automotive Engineering
China Agricultural University
M.S. - Mechanical Engineering
Stevens Institute of Technology