Manage Microbiology Lab and Staff, Assist in QMS, Write Procedures, Protocols, and Reports. Interface with the FDA and other regulatory agencies. Write and submit 510k's for our products and accessories. Provide technical and clinical support to our customers and engineers.

Assist Sterilizer in developing their validated device list for their newly released VHP Sterilizer

Assist customers in updating their quality systems to meet current ISO 13485 standards and submit 510(k) to the FDA. My primary focus is on validation activities

Assist FiberTech in aligning processes to meet current ISO 13485 standards and become certified.

Manage the FarbTek product lines and handle any regulatory issues. Investigate any new technology as well as implement it into our current product base. Increase customer base by working with Product Developers in various fields to help them utilize our coloring technology.

Support customers with customers with educational programs and any infection control issues. Oversee validation testing on replacement components. Work with company to develop any potential new business and medical device technologies. Manage all GPO contracts.

Support owner in any medical device development projects that require scientific testing.

Manage Reprocessing and Repair Product lines along with Corporate Repair Specialists (CRS). Responsible for increasing repair revenue by adding CRS in select locations and developing customer-specific programs. Responsible for training of Sales Representatives and Customers on various educational issues. Worked with Regulatory and German Headquarters on 510K submissions and all validation testing.

Managed two divisions in R&D Product Development and Device Testing. Responsible for ushering new products from development to release and through any subsequent revisions or design changes. Also established a fee-per-test structure in the Device Testing Program. Released an average 16 new products per year and 30 revisions per year. Microbiologist expert for legal department. Coordinated testing on products with our labs in Canada and United Kingdom. Managed engineering/labeling/microbiology departments. Acted as a liaison between various Medical Device Manufacturers and STERIS. Responsible for any regulatory audits or issues form FDA/TUV/Health Canada/ISO for products under my management.