Paul Korat

About Paul Korat

16 plus year of Design & Development, Quality Assurance, Quality Control, Risk Management, & Supply Chain, Engineering and management expertise for Medical device and healthcare products.• Risk assessment & management champion, using FMEA (DFMEA, PFMEA), FTA, DOE, SWOT and SPC, as per ISO 14971 Standards and requirements for medical device• Electronics, Electro-mechanical and Mechanical engineering products quality expertise with BSEE & MBA• Design Control, NPD, NPI, Design Transfer, Reliability, Verification, Validation, & Test expertise-10 + Years • Quality and Audit expert as per ISO 13485:2016, AS 9100 D and ISO 9001:201, FDA 21 CFR 11, 820, & 830 plus EU-MDR 2017/745 UDI and labeling requirements• Certified Quality Engineer (CQE) & Certified Quality Manager/Organizational Excellence (CMQ-OE): Championship in Design Transfer, New Product Development (NPD), New Product Introduction (NPI) Project management with Jigs, Fixtures, assembly, tests with machine & equipment IQ, OQ & PQ qualification for production and manufacturing as per Six Sigma and Lean standards• IPC A-600, IPC A-610 (CIS), IPC A-620 & IPC-J 001(CIT) certified trainer & product inspector (CIS)• Product FCT, BCT, Reliability test experts as per CE, CSA, IEC 60601-1, LabVIEW, and UL • Engineering problem solver by using tools like 8D, APQP, CAPA, DOE, FMEA, Minitab, MRB, NCMR, RCCA, SCAR, SPC with FAIR and PPAP• Believer in strong relationship & collaboration to deliver advancement & results with integrity & honesty as per ROI and ROA requirements with KPI and Management Review expertise with Engineering documentation• Capabilities & skills to bring meaningful advancement through quality principles of Lean & Six Sigma-DFSS-Design For Six Sigma & SPC

Experience

1. Principal Engineer

   Alcon

   Jun 2022 — Present · Lake Forest, CA, US

   Develop & execute V&V test protocols for Alcon Medical Device per FDA, ISO, ISTA, & L10 reliability standards Test protocols, Execution and report writing responsibility as per ISO 14971, 13485, FDA 21 CFR 820 standards Product aging & reliability test profiles, test, conclusions & Issue resolution responsibility for Alcon Products Responsible to verify documentations and reports as per DHF and DMR per ISO 13485, FDA 21 CFR 11, 820, Responsible for design and development of ESS, HALT, HASS, and ISTA tests for product Quality and Reliability

Education

• California State University, Fullerton

  Six Sigma Green Belt, Certification, Quality Control Technology/Technician

  2008 — 2008

• Webster University

  Master of Business Administration - MBA, Business Administration and Management, General

  2011 — 2013

• The US Army

  BCT, CLS, Fire Prevention and Safety Technology/Technician, Water treatment

  2008 — 2012

• Bangalore University

  Bachelor's degree, Electrical and Electronics Engineering

  1988 — 1994

• Bangalore University

  Bachelor of Engineering (B.Eng.), Electrical, Electronics and Communications Engineering

  1987 — 1992