Experience

Advanced Quality System Solutions, San Diego , CA  2007 – present
A full service quality system consulting company with focus on medical device regulations and standards.

Principal/Quality System Consultant

Medical Device Consultants, Inc., San Diego, CA 2005-2007
A Provider of worldwide quality system, clinical, and regulatory consulting services to medical device companies

Quality Systems Consultant, reported to Director, Quality and Compliance Services

BSI (British Standards Institution), Management Systems Reston, VA 2000-2005
A Leading provider of quality management system registrations and assessment services spanning a wide variety of industries including: medical device, aerospace, automotive, and telecommunications.

Western Area Manager, reported to Assistant Regional Vice President (2003-2005)

Medical Device Lead Assessor, reported to west coast area manager (2000-2003)

Genzyme Corporation, Genzyme Surgical Products Division Tucker, GA 1996-1999
A global, diversified healthcare products company. GSP division manufactures surgical instruments (manual, endoscopic and minimally invasive applications), equipment, and accessories for cardiovascular, plastic, and general/GYN surgical procedures.

Director, Regulatory Affairs/Quality Assurance, reported to the Vice President of Product Technology and RA

Ortho Development Corporation, Draper, UT 1994-1996
A start-up manufacturer of total joint reconstruction devices and surgical instrumentation. A subsidiary, Orion Medical, manufactures alternating pressure air mattresses, stereotactic systems and accessories.

Manager, Regulatory Affairs/Quality Assurance, reported to the CEO

Kirschner Medical Corporation, (Biomet) Fair Lawn, NJ1993-1994
A manufacturer of total joint reconstruction devices and surgical instrumentation, orthopedic support products, endoscopic video equipment and accessorie s. Acquired by Biomet, Inc. in November, 1994.

Corporate Regulatory Compliance Specialist, reported to the Director of Regulatory Affairs/QA

C.R. Bard Corporation (Baxter), North Reading, MA 1989-1993
A Fortune 500 manufacturer of a software-driven infusion pump used to administer and deliver analgesic drug therapy. Acquired by Baxter Healthcare Corporation in March, 1993.

Quality Specialist, reported to the Quality Manager