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Quality Systems Engineering (QSE) professionals are seasoned, senior executives from the medical industry who have made significant contributions to major corporations. Their vast knowledge and experience qualifies QSE executives to provide strategic and implementation services, delivering results for virtually all your organizations needs worldwide. In addition to our core team QSE uses the services of many other former industry executives each bringing a unique set of skills and talents to your specific project.

Our Core Team

 

Richard Bliss

Richard BlissQSE President


Rich has 40 years of experience in the medical device and diagnostics industry specifically in the areas of quality systems (QSR, ISO 9001, and ISO 13485), regulatory affairs (pre-market notifications, responses to FDA-483’s, Warning Letters, Consent Decrees, etc.), regulatory compliance, manufacturing, sterilization, and environmental controls.


As the President of Quality Systems Engineering, Inc. Rich continues to work directly with clients to identify and implement compliant and business friendly solutions for the most common problems in the Medical Device industry today. His highly successful track record with clients, both large and small, is supported by the extremely positive outcomes that our clients have had with FDA and/or Notified Bodies after to remediate their issues. He is certified as a lead assessor for ISO 9001. Rich has published several articles on quality systems and regulatory compliance for the medical device industry. He holds a bachelor's degree in Chemistry. Contact Rich at rich@qsenet.com.

 
Tim Gaskin

Tim GaskinQSE Senior Consultant


Tim has 37 years of experience working in regulated industries with over sixteen years in the medical device and diagnostics industry and ten years with personal care, cosmetics, over-the-counter drugs (OTCs) and food products. His experience includes quality systems design, development and management in addition to experience in auditing (FDA, ISO, due diligence), regulatory affairs (FDA inspections, regulatory submissions, warning letter responses, compliance), quality engineering, process validation, metrology, research and development, laboratory management, quality training and manufacturing operations. Tim has held senior management level positions and has led or participated in several teams that achieved ISO 9001 and/or ISO 13485:2003 registration.

Tim is accredited by the American Society for Quality (ASQ) as a Quality Auditor and Quality Engineer. He has lectured and conducted training extensively on a variety of quality and regulatory topics. He holds a degree in chemistry. Contact Tim at tim@qsenet.com.

 
 

John Barrett – QSE Senior Consultant

 John has more than 38 years in quality management with a broad background in different industries. He has over 23 years in the medical device industry with experience in quality assurance, quality systems, and regulatory compliance.  Areas of expertise include quality systems (QSR, GMP, ISO13485, ISO 9001, EU MDD, JPAL), auditing, training on quality concepts & tools, Six Sigma Tools, design controls, manufacturing processes, process validation, corrective action & preventive action, root cause analysis, supplier quality management, benchmarking, team building, Baldrige Criteria for Performance Excellence, strategic planning and balanced scorecards/strategy maps.

 

John is certified as a RABQSA Lead Auditor (Certificate # Q05310) for ISO 9001, ISO 13485  & 21 CFR 820.  He is ASQ Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), Manager of Quality/Organizational Excellence Certification – (CMQ/OE). John also participates in developing new examinations for ASQ Certifications and contributed to ASQ Quality Auditing Handbook, 1st & 2nd editions.  He is certified as a Six Sigma Greem Belt from the North Carolina State University  and is a Senior Member of ASQ,  RAPS, AAMI, the American College of Healthcare Executives (ACHE), and the Institute for Global Ethics. 

 

John holds a BSEE in Systems Engineering from the University of Tennessee, Knoxville, TN  and a MBA from East Tennessee State University, Johnson City, TN. Contact John at john@qsenet.com.