Lee Burnside

About Lee Burnside

Quality Standards• ISO/TS 16949, ISO 9001, ISO 13485, and ISO 14001, ISO cGMP• USP, OSHA, cGLP, 21 CFR Part 110 and 21 CFR Parts 210 & 211 • Process Validations, IQ, OQ, PQ, Process Mapping• Developing and implementing quality studies and CAPA• Product specifications, Supplier requirements, Testing, Inspections, Product/Materials verification, • Equipment Calibration, Non-conformances, process audits, ISO audits, collecting objective evidence, and writing reports.• Quality Project Management, Process Improvement, 5S, 8D, A3 Story Boards• Process Documentation and Document Control

Experience

1. Quality Engineer

   Medtronic

   Aug 2013 — Present

   Solid base knowledge of the Quality System Regulation (CFR 820)· Participate in applicable Quality System Standards and Regulations, FDA, supplier, customer and internal audits as required.· Conduct GMP training for all new hires as part of their orientation. Provide refresher training as needed for all employees.· Provide quality engineering support in new product development. · Review new and modified product designs for safety, testability, reliability, serviceability, and manufacturability. · Perform product risk assessment and failure mode effects analysis (FMEA).· Create verification and validation test plans and conduct prototype testing and analysis for reliability, standards compliance, and product requirements compliance.· Perform statistical analysis of test results.· Conduct quality audits and develop subsequent preventive action programs· Support the nonconforming product and material on hold systems, including placing product on electronic hold· Investigate and respond to customer complaints, including facilitating Material Review Boards to determine disposition of nonconforming product.· Determine root cause/corrective and/or preventive action for material on hold, customer complaints, externally generated Supplier Corrective Actions (SCARs) and CAPAs.· Evaluate internally generated CAPAs for root cause and effective corrective actions.· Update/revise product plans of control and other site documentation where necessary.· Assist in process improvements as related to improved quality and yields.· Approve change notices (CNs).

Education

• Greenville Technical College

  Associate of Arts (A.A), Applied Chemistry

  1995 — 1997

• Clemson University

  Bachelors of Science, Biological and Physical Sciences

  1998 — 2001

• Greenville Technical College

  Associates of Applied Science, Mechanical Engineering Related Technologies/Technicians

  1994 — 1996

Skills

• Gmp
• Quality System
• Project Planning
• Microbiology
• Usp
• Ms Programs
• Visio
• Cglp
• Ms Project Manager
• Cleaning Validation
• Manufacturing
• Powerpoint
• Microsoft Office
• Chromatography
• Pharmaceutical Industry
• Sop
• Laboratory Information Management Systems(Lims)
• Fda
• Lims
• Six Sigma
• As400 System
• Quality Auditing
• Aseptic Processing
• Chemistry
• Lean Manufacturing
• Pharmaceutics
• Change Control
• Process Validation
• Testing
• Capa
• R&D
• Validation
• Environmental Compliance
• Statistical Process Control
• Hplc
• Microbial Identification
• Environmental Monitoring
• Method Validations & Qualifications
• Osha
• Project Management