Quality Assurance Specialist
THE UNIVERSITY OF BRIDGEPORT
Completed coursework towards BS
Biology (Sep 1985)
Business Level Speaking
Expertise in International Regulatory
Germantown CPD Certified
Proactive professional with 30+ years of experience and a proven knowledge of cost avoidance, efficiency improvement, and just-in-time. Aiming to leverage my skills to successfully fill the Quality Assurance Specialist role at your company. PROFESSIONAL EXPERIENCE
Agency Consulting, Germantown, TN / Jul 2013 – Present
Guidance for Medical Device Manufacturers
Analyze operations to evaluate performance of a
company or its staff in meeting objectives or to determine areas of potential cost reduction, program improvement, or policy change.
Confer with board members, organization officials, or staff members to discuss issues, coordinate activities, or resolve problems.
Interpret and explain policies, rules, regulations, or laws to organizations, government or corporate officials, or individuals.
The Woundcare Co. LLC, Memphis, TN / Aug 2005 – Jul 2013
Achieved product clearance from Taiwan/China FDA
Constructed and implemented FDA and international Compliance
Delivered qualified vendor to produce cost-saving manufacture of products
Wright Medical Technologies, INC, Arlington, TN / Jul 1993 – Jul 2004
Obtained over 150 FDA market clearances to market
Managed with a Quality First attitude resulting in zero recalls.
Introduced and implemented Lean Manufacturing