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.
Our Team
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Richard Bliss – QSE President
Rich has 33 years of experience in the medical device and diagnostics industry specifically in the areas of quality systems (QSR, ISO 9000, 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. He is certified as a lead assessor for ISO 9000 through Gilbert and Associates (BSI). Rich has published several articles on quality systems and regulatory compliance for the medical device industry.
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 has lectured as a guest speaker on quality systems, regulatory affairs and compliance to FDA regulations for Medical Device & Diagnostics Industry magazine (March 1998) and for the Regulatory Affairs Professional Society on conducting successful QSR audits with FDA (May 1999). Rich continues to train personnel at clients and at seminars on all aspects of quality systems and regulatory compliance methods. Contact Rich at rich@qsenet.com. |
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Tim Gaskin – QSE Senior Consultant
Tim has over 30 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.
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Susan de la Vega – QSE Senior Consultant
Susie has 34 years of experience in the medical device, diagnostics and biologics industries particularly focused in quality systems and regulatory compliance, regulatory affairs (including pre-market notifications and approvals, Clinical audits, FDA enforcement responses, and notified body and competent authority interaction for adverse events and registrations as well as audits), aseptic techniques, sterilization, laboratory techniques, complaint management, continual improvement and manufacturing. She has acted as management representative for several organizations and in that role has led ISO certification and surveillance efforts. During her corporate tenure, Susie has had responsibility for domestic and international facilities.
Susie is accredited by the American Society for Quality (ASQ) as a Certified Quality Auditor (CQA #11484) and by BSI as an ISO Lead Auditor (#95417A-35680).
Susie holds a bachelor’s degree in Biology and an MBA and is a member of the Sigma Beta Delta National Honor Society in Business, Management and Administration. Contact Susie at susie@qsenet.com.
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