Frank Defazio Email & Phone Number

Massachusetts, United States

Acton, Massachusetts, US

Global Head of Product Monitoring. Oversee all activities related to post-market surveillance and post-market compliance/commercial quality assurance for Insulet products globally (including, complaint management, vigilance/reportable events, RFAIs, product safety monitoring and reporting (PSUR/PMCF), post-market risk analysis/health hazard analysis, field.

Acton, Massachusetts, US

Served as interim/acting head of post-market as an independent consultant from Beyond Compliance.

• As Executive Director/Chief Executive, responsible for all facets of the company, including Business Development, Marketing, Sales, Finance, Operations, and Client Engagement/Project Management.Beyond Compliance, LLC.
• QMS: Building or improving Quality Management Systems (in their entirety or targeted to specific areas of need): design, development, implementation, post-M&A integration, inspection-readiness, turnaround.
• LDTs: Helping Clinical Laboratories, designers and manufacturers of Personalized Medicines, and other organizations that design and/or produce laboratory developed tests (LDTs) prepare for and meet present and future.
• QIS: Delivering unique services for Quality Management Software (QIS, e-QMS) design and adoption.
• Leadership: Providing interim QA/RA leadership or coaching during organizational transitions (particularly in the areas of Quality Systems, Risk Management, Post-Market Surveillance, and Design/Development).Visit us at.

As Subject Matter Expert and Principal Consultant, directly lead and execute Client projects as an embedded resource and advisor. Projects across 5 client companies included compliance gap assessments; Risk Management, Medical Safety and Design Control overhauls; Change Control, Supplier Qualification, and Design Transfer improvements; QMS redesigns.

US

"Side hustle" for nearly three decades. Training in sports nutrition, plant-based nutrition, health analytics, and foundational ayurveda. Books available (print and Kindle editions). Visit us at: https://www.eattoimprove.com/

Minneapolis, MN, US

Global Head of Product Monitoring for MITG. After acquisition by Medtronic: Covidien Group-wide (Minimally Invasive Therapies Group-wide) Post-Market Quality/Compliance responsibilities across the entire product portfolio. (Left role after 1 year to start consulting business.)☞Led post market transformation to optimize processes and unite team of >150.

Minneapolis, MN, US

• Global Head of Corporate Quality Systems for Covidien. Before and during acquisition by Medtronic: Covidien-wide (enterprise-wide) responsibilities as part of corporate Global Quality organization. Asked to lead.
• Corporation-wide and Corporate-level Quality Processes, Structures, and Strategies: Corp. QMS Development, Maintenance & Continuous Improvement (including global corporate policies and procedures).
• Corporation-wide Quality Technologies: Quality Analytics/Quality Business Intelligence; Quality Information System (QIS) Portfolio & Project Management; Development, Validation, Implementation, & Maintenance; and.

Minneapolis, MN, US

Head of Quality Systems, Quality Compliance, & Product Monitoring for Vascular Therapies. Prior to acquisition by Medtronic: Business-wide responsibilities for the Vascular Therapies Global Business Unit of Covidien (revenue of $2BB USD). Promoted out of GBU to Corporate-level role above.☞Served as Management Representative for the Vascular Therapies GBU.

Paris, France, FR

Led Program and Change Management for Genzyme Genetics. Before, during, and after acquisition by LabCorp: Business-wide responsibilities in Genzyme Genetics focused on transforming and sustaining performance of the enabling information technology "nervous system" of the entire enterprise to ensure Maintenance of Business (including diagnostics and.

Paris, France, FR

Led Genzyme's product events management group. Prior to acquisition by Sanofi (which occurred in April 2011): Worldwide (Genzyme Corporation-wide) program management and functional responsibilities, as part of the Corporate Quality Systems group, in leading the development, implementation, management, and improvement of Post-Market Surveillance/Commercial.

US

Led New Product & Technologies PMO and Head of Design Quality. After acquisition of Impath, Business-wide responsibilities in Genzyme Genetics, across all product franchises (reproductive health and oncology) and technology platforms, with emphasis on design quality/design assurance and new product/new technology PMO/project portfolio management (selection.

US

Site Quality Head, MDX Regulatory Head, and business-wide change agent. Site-wide and Business-wide responsibilities in Genzyme Genetics as a QA/RA/QI generalist and design quality/V&V specialist. ☞Evolved QMS toward medical device/IVD standards and best practices.☞Oversaw, assembled, authored >12 successful regulatory submissions.☞Established more robust.

Quality Assurance "chief, cook and bottle-washer". Responsibilities in QA with emphasis on QMS development, implementation, and oversight for compliance with 21 CFR 820 and ISO 13485. ☞Built QMS from the ground up. ☞Managed Document Control.Areas of focus: document and data control; equipment and inventory control; purchasing and materials control; design.

Logistics, shipping/receiving, facilities at Finlay Fine Jewelry and U.S. Army Materials Technologies Research Laboratories.Finlay was the largest operator of licensed fine jewelry departments in department stores throughout the United States.The Materials Technology Laboratory (MTL) was a research facility under the U.S. Army Materiel Command that.

Certificate: Disruptive Strategy With Clayton Christensen

Certificate Plant-Based Nutrition, Human Nutrition

Data Science

Master'S Of Science, Management (Business Continuity, Security & Risk Management)

Critical & Creative Thinking/Education

Bachelor'S, Ethics And Philosophy

Associate Of Arts - Aa, Liberal Arts And Sciences/Liberal Studies