V
Vin Cafiso

Ex-FDA | Strategic Leader | Regulatory Compliance | Quality | Medical Device | IVD | Biotechnology

New York, NY

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About

Ex-FDA Investigator, Regulatory Compliance, Quality Assurance, and Quality Systems expert with extensive experience in creation, maintenance, and auditing of quality system documentation for sterile medical devices and in vitro diagnostics (IVD) to ensure compliance with domestic and international quality and regulatory requirements. Experienced internal and supplier auditor having practical experience with FDA regulations and site inspection procedures. Experienced in European and Global quality system standards such as ISO 13485, ISO 9001, and the EU Medical Device Regulations (MD/AIMD, IVD). Also experienced in working with contract manufacturers to ensure that product is manufactured in compliance with US and international quality system requirements. Specialties: FDA Regulations / QSR FDA Inspection Procedures (QSIT) Quality Assurance Quality Systems Quality Control Quality Planning Regulatory Compliance Change Control Culture Change FDA Readiness Internal, Supplier, Third Party Audits Inspection & Testing Process Control Calibration CAPA Control of Nonconforming Product Qualification & Validation - MVP Design Control Management Review Project Management Clinical Trials Sterilization Product Stability ISO 13485 ISO 14971 ISO 9001 ISO 19011 AIMD / MD / IVD / Biotechnology Start-up companies Class I, II, III Medical Devices Expert Witness - Depositions

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Quality
Audit
Work experience
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2019 - Present

Smith & Nephew

Senior Director, Regulatory Compliance & Global Audit

Responsible for ensuring that the S+N network complies with applicable global regulatory standards as well as key Global S+N policies. This remit includes Global Audit, Regulatory Compliance, site/entity registration reporting, site regulated activity tracking, external inspection readiness and commitment tracking, and clinical quality.

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2018 - 2019

Smith & Nephew

Senior Director, Global Q/RA Audit

Led the Global Quality and Regulatory Affairs audit group and ensured that the Global Operations network complied with applicable global regulatory standards and provided guidance and oversight on the audit program.

2016 - 2018

BD

Vice-President, Quality & Regulatory Compliance

For both C.R. Bard and BD, I ensured that the global Corporate audit and compliance programs provided an accurate ongoing assessment of the organization's compliance profile across all facilities and operations, that the programs and activities necessary to address compliance gaps as well as new requirements were implemented in an efficient, measurable, and effective manner.

2009 - 2016

BioArray Solutions, An Immucor Company

Senior Director, Quality Assurance

I led the overall Quality Assurance / Engineering, Quality Control, Field Quality, Regulatory Compliance, and Software Quality Assurance programs in support of IVD medical device research, product design and manufacturing. I had full QA oversight over all Design Control activities as well as managing all internal, supplier and third party audits and compliance activities for the company. In May 2014, we received FDA PMA approval of our PreciseType BeadChip Kit - the first device of its kind on the market! In August 2015, a week long FDA inspection resulted in zero observations.

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2005 - 2009

Impulse Dynamics

Director of Quality Systems

I led the overall Quality Assurance, Document Control, Repair, and Servicing programs in support of Class III Active Implantable Medical Device (AIMD) design and manufacturing. I had full QA oversight over all Design Control and Clinical activities as well as managing all internal, supplier and third party audits and compliance activities for the company. Worked very closely with contract manufacturer and sterilizer in Uruguay (CCC) to ensure conformance to QSR and ISO 13485 requirements.

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2000 - 2005

Getinge

Manager of Quality Systems (Datascope Corp.)

Formerly Datascope Corp., I led the overall Quality Assurance and Compliance programs in support of Class III wound closure and vascular graft medical device design and manufacturing. I had full QA oversight over all Design Control activities as well as managed all internal, supplier and third party audits, compliance activities and recalls for the company.

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1994 - 2000

US Food and Drug Administration

Investigator - Medical Devices

Experienced medical device and IVD Investigator - I conducted hundreds of complex inspections of manufacturers both domestic and abroad as a member of the Foreign Inspection Cadre - resulting in Form FDA 483 observations, Warning Letters, Injunctions, and Seizures. I was awarded the Outstanding Achievement Award for inspection excellence.

Education

Wagner College

Bachelor of Science - BS, Biology, Chemistry

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