Crystal Lake, Illinois, United States
Specialties: Lean Six Sigma Black Belt
Responsible for managing all product quality aspects for Typenex, including interfacing with manufacturing partners on product quality, developing test methods and new product validation activities, and managing Typenex’s internal product feedback and complaint handling system. Responsible for maintaining the Typenex ISO 13485 quality system as our Management Representative as well as leading regulatory administration efforts as required.
• Administration of the site’s Customer, Internal and Supplier Audit Programs including performing the Lead Auditor role for the Supplier and Internal Audit Programs • Managed major site-wide Quality Systems improvement initiatives including the optimization of the site’s change control, internal audit and supplier audit programs. • Regulatory Inspection support including audit support and authoring response letters • Administration of the site’s Quality System Program including Corrective and Preventative Action (CAPA), Quality Management Review, Change Control and Document Control procedures.
• Lean Six-Sigma Site Deployment Leader for Woodstock’s sterile blow/fill/seal facility. Oversaw the Operational Excellence program responsible for 5 million dollars in yearly savings (2008). • Managed major site-wide compliance initiatives including the Quality by Redesign program. • Instituted an Overall Equipment Effectiveness (OEE) measurement program. • Worked with site leadership to develop site-wide Key Performance Indicators (KPI) and translate them to visual (plant) metrics. • Developed LSS training materials and conducted site-wide training courses. • Supported the role out of Catalent’s Middleton, Wisconsin facility Lean Six Sigma program.
• Responsible for the transfer of new products into Manufacturing. Coordinated the efforts of the Client Representatives, Manufacturing and Quality/Regulatory departments to ensure that project goals were met in a timely fashion.
• Responsible for the manufacturing and testing of RenalTech’s BetaSorb device. o Oversaw the expansion of RenalTech’s facility from a 1,500 sq. ft. Research and Development laboratory to a 9,000 sq. ft. integrated clinical manufacturing pilot plant. • Project Manager for RenalTech’s BetaSorb project. Coordinated the efforts of Research and Development, Manufacturing, Quality, Clinical, Regulatory and Finance Departments to ensure that project goals were met. • Responsible for the creation and oversight of RenalTech’s Quality Control, Document Control, and Process Engineering Departments. • Responsible for a combined Manufacturing, Quality Control, and Engineering budget of $2.25 million dollars a year.
• Responsible for the optimization, scale, and manufacturing of SSI’s sealants. Brought SSI’s lead product from concept to human clinical trials. • Obtained Investigational Device Exemption (IDE) for SSI’s lead medical device candidate. • Responsible for the creation and oversight of SSI’s Quality System • Lead Auditor for SSI’s Supplier Audit Program • Directed the design and construction of both SSI’s Research and Development laboratories and its class 100,000 pilot plant. Facility completed on time and within budget. • Conducted raw material vendor audits.