marc dickens

Managed two departments (Quality Training and Internal Audit) with six employees ⋅ In addition to the responsibilities documented for Principal Internal Auditor, I was responsible for working with departmental managers to define employee training needs and overseeing the development of training materials targeted mainly at technical manufacturing employees ⋅ Worked with the College of the Canyons to define training needs of employees, develop curricula and ensure reimbursement for training received associated with State grant ⋅ Delivered training to entire company in areas of expertise – Quality System Regulations and product manufacturing overview.

Independently scheduled and conducted inspections of medical device manufacturers, tanning salons and medical device salvage operators ⋅ Commissioned as an Officer of the U.S. Department of Health and Human Services to conduct inspections of regulated firms on behalf of the Food and Drug Administration ⋅ Trained other State investigators on current inspection techniques / requirements.

Maintained daily bookkeeping records in proprietary accounting database. Managed checkers and sackers concerning breaks, staffing levels, and immediate duties to ensure customers proceed through check stands as quickly as possible.

* Service and sales of medical laboratory equipment and sales of service contracts to hospitals, laboratories and clinics in Southeast Texas, Louisiana, Arkansas, Kentucky, and one account in Mexico * Maintained field contact with clients and customers to ensure complete satisfaction * Attended auctions of used laboratory / medical equipment to submit company bids * Coordinated the collection and shipment of equipment to company refurbishment facilities in Fort Worth, TX

* Responsibilities included: * Contact person for all Health Authorities (FDA, DEKRA, KEMA, Health Canada, Japan PMDA, TGA). * Facilitated and managed all Health Authority inspections as well as all corporate inspections. * Managed the Internal Audit program for four Biosense Webster facilities located in Irwindale, CA; Diegem, Belgium; Juarez, Mexico; and Haifa, Israel. * Discussion, and escalation (when necessary), of serious quality issues that could affect product performance or patient safety / well being. * Managed investigations associated with quality issue escalation process. * Management and oversight of all field actions and communications with Health Authorities. * Facilitated quarterly Quality System Management Reviews * Oversaw the responsibilities and activities of the Compliance Coordinator * Participated in Corporate initiatives to improve the Biosense Webster Quality System concerning Internal Audit, CAPA and Compliance / Audit Readiness. * Implemented an instance of ETQ at Biosense Webster to allow tracking and trending Internal Audit findings across all sites.

* Chair Quality Improvement Committee with a focus on Quality System and process improvements. * Identification of potential process improvements and formation of work groups to implement change. * Oversight of metric data collection, review and analysis. * Hosting of client and Health Authority audits in the US.

Responsibilities included: Independently scheduled and audited medical device firms for compliance with the FDA Quality System Regulations ⋅ Trained new investigators to conduct a broad spectrum of inspections ⋅ Trained experienced investigators in the inspection of medical device manufacturers ⋅ Presented needed improvements in quality systems directly to Heads of Quality / Regulatory Affairs, CEOs and physicians ⋅ Developed reports of findings concerning inspections of FDA regulated firms ⋅ Acted as interim supervisor during team supervisor’s absence ⋅ Conducted inspections / investigations of domestic and foreign firms, including: o Medical device manufacturers o Biomedical research / clinical trials o Animal feed / veterinary medicine manufacturers o Food manufacturers

* Responsibilities included: * Production of mold (growing, harvesting, drying and packaging) to be used in the production of allergen extracts * General laboratory maintenance (cleaning, sterilizing glassware, media preparation) * Production of vials of allergen extracts utilizing aseptic technique * Environmental sampling of the aseptic core to ensure the clean room is within parameters * Review of production paperwork and physical product to ensure quality

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