joseph farinella

Worked in Global Supplier Quality. Audited domestic and international suppliers and manufacturers (ISO 9001:2008, ISO 13485:2003, ISO 14971:2007, EU-GMP, Internal Regulations). Represented Supplier Quality on project core teams.

Worked in Medical Products Quality Systems. Served as a liaison between the division and global manufacturing plants to drive specification changes and quality improvement initiatives. Global Project Manager for change control IT tool deployment in Medical Products.

Worked under the instruction of Dr. Alexander Ng and Dr. Sandra Hunter at Marquette. Conducted muscle fatigue studies and aided in the setup and analysis of MRI scans (3T magnet) at the Medical College of Wisconsin.

Worked in Global Infusion Systems (GIS) Systems Engineering. Analyzed Use Cases and performed extensive competitive analysis/benchmarking regarding Magnetic Resonance (MR)-Safe infusion pumps.

Worked in Corporate Quality. Developed and implemented the NantPharma Supplier Quality Program and Internal & External Audit Programs to ensure overall corporate and plant compliance. Authored multiple corporate procedures and performed 20+ supplier audits per year across multiple industries. Created the Supplier Scorecarding program to quantitatively rank suppliers and asses risks to business.

Managed the Quality Assurance Department's staff and activities. Maintain product specifications and inspection procedures for all manufactured products. Lead continuous improvement initiatives, including those related to nonconforming product, internal/external audits, data analysis, document/record control, and others. Subject Matter Expert for the corporate Quality Management System (QMS).

Worked in Materials Science and Engineering in Applied Science and Technology. Project Lead for the Dry Site Sterilization project. Performed DSC on films/resins and executed WVTR testing protocols. Invention Record (IR) Filed for Dry Site Sterilization Project in December 2009: Membrane Tube Temperature and Relative Humidity Sensor

Worked in Disposables Engineering. Project Lead for two Supplier Notices of Change (SNCs). Significant project contributions in the areas of Risk Management and V&V. Created exploratory CAD models for Renal Therapy Optimization and presented to PACt members.

Leader of the site Quality System for the company's largest domestic hemodialysis concentrate manufacturing facility. Serve as the Management Representative per 21 CFR Part 820. Facilitate US Food and Drug Administration (FDA) and other internal/external inspections. Oversee all aspects of inspection, testing, and release for finished products.

Fresenius Medical Care North America (FMCNA) is the premier health care company focused on providing the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis facilities, outpatient cardiac and vascular labs, and urgent care centers, as well as the country's largest practice of hospitalist and post-acute providers, Fresenius Medical Care provides coordinated health care services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world's only fully vertically integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products, and renal pharmaceuticals. For more information, visit the FMCNA website at www.freseniusmedicalcare.us. For information on dialysis services, visit the Fresenius Kidney Care website at www.freseniuskidneycare.com.