Joseph Azary Mba Cqa Cmda Email and Phone Number
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Over 30 years of medical device experience with a focus on regulatory affairs and quality assurance. Current Chief Advisor & Compliance Officer for AzTech Regulatory & Quality LLC. Former Vice President of Quality & Regulatory at Z-Medica, former head of regulatory and quality consulting group at Orchid Orthopedic Solutions and former owner of Azary Technologies LLC, a consulting firm specializing in regulatory and quality for the medical device industry. Azary Tech was acquired by Orchid Orthopedic Solutions in 2008. Held quality and regulatory positions at U.S. Surgical, Johnson & Johnson, Sekisui Diagnostics, and Fujifilm Medical Systems (division of Fujifilm). Worked with over 180 companies on various consulting projects including FDA compliance, FDA submissions, European and Canadian Compliance, ISO certification, training, quality system development, and quality auditing. During my career I have managed and coordinated dozens of FDA Inspections, hundreds of ISO audits (from BSI, TUV, Intertek, Lloyds, etc). I have written and submitted over 100 510(k) submissions, submitted several PMA Supplements and Annual Reports, prepared dozens of Technical Files for CE Certification and handled hundreds of international registrations in countries around the world. My philosophy is KEEP IT SIMPLE and BALANCE between patient safety, product quality, compliance, efficiency, risk, cost, and business needs. Common Sense and Integrity all the way. Regulatory Affairs Certified (RAC), Certified Quality Auditor (ASQ -CQA). Certified Biomedical Auditor (ASQ - CBA). Bachelors in Biological Science and Masters Degree in Business Administration with concentration in Public Health (MBA - PH). Pursuing Graduate Studies in Medical Device Regulatory Affairs at Northeastern University.Author of book "Vampires, Warriors and Nomads: The History, Mythology and Folklore of the Hungarians". Specialties: Quality System, Quality, Regulatory, Biology, Medical DevicePersonal: I believe you should live each day to the fullest, balance your life between family, work, spiritual beliefs, recreation, and health. Conduct your daily activities with 100% effort and ethical and moral integrity.
Aztech Regulatory & Quality Llc
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Chief Advisor And Compliance Officer And Co-OwnerAztech Regulatory & Quality LlcShelton, Ct, Us
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Chief Advisor & Compliance Officer / Co-OwnerAztech Regulatory & Quality Llc Nov 2021 - PresentShelton, Connecticut, UsAzTech Regulatory & Quality serves the medical device industry with realistic approaches for regulatory submissions, quality management systems and compliance. Aztech Regulatory and Quality specializes in small to medium sized medical device companies, virtual companies and start-ups. Aztech has a network of regulatory, technical, quality and medical professionals to assist with a large variety of regulatory and quality projects. Aztech provides the following services:- FDA 510(k) Submissions - Quality System Development (ISO 13485 FDA QSR EU MDSAP)- European Union EU MDD / EU MDR Technical Documentation for CE marking- International Regulatory Registrations - Auditing - Supplier Auditing and Qualifications - Due Diligence - Regulatory Strategy Joseph is the Chief Advisor & Compliance Officer at Aztech Regulatory & Quality bringing over 30 years of medical device regulatory and quality experience.
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Principal Consultant, Quality And Regulatory AffairsOriel Stat A Matrix Nov 2021 - Jan 2024Washington, Dc, UsAs an Affiliate of Oriel STAT A MATRIX, Joseph will provide training and/or other services. Oriel STAT A MATRIX provides life sciences organizations with consulting, training, and audit support to achieve compliance with US FDA and global regulations like EU MDR. -
Vice President Of Quality & RegulatoryZ-Medica, Llc Jun 2012 - Oct 2021Morrisville, Nc, UsZ-Medica is a fast growing company in the hemostatic market selling proprietary products to control bleeding. The products are sold to hospitals, surgeons, EMS (EMTs / Ambulance), Law Enforcement, Military and OTC products for Consumers. Z-Medica was acquired by Teleflex Medical on December 28, 2020. 2012 - Hired as VP QA2014 - Promoted to VP QA & International Regulatory2018 - Promoted to VP Quality & RegulatoryHands-On Executive responsible for Quality Assurance, Compliance, Regulatory and International Regulatory Affairs activities including quality system development, corrective actions, metrics, improvements, management reviews, health & safety, supplier quality, FDA compliance, ISO certification, MDSAP, training, coordinating internal audits, and foreign country registrations (including Brazil, South Korea, Japan, Australia, Russia, Canada, European Union, Saudi Arabia, UAE, Thailand, Taiwan, Philippines, Singapore, Israel, and China). Obtained CE marking for class 3 animal tissue device and a class 3 medicinal device. -
Director Regulatory And QualitySekisui Diagnostics, Llc Oct 2010 - Jun 2012Burlington, Ma, UsResponsible for Regulatory Affairs and Quality Assurance for U.S. operations including handling FDA inspections, ISO audits, regulatory strategy, quality system improvements, corrective actions, health & safety, trending and metrics, Canadian licensing, EU/CE marking, and compliance. The company offered a variety of IVD (in vitro diagnostic) devices. American Diagnostica was integrated into Sekisui Diagnostics, LLC (Framingham, MA) and is part of Sekisui Chemical (Japan). The Stamford facility manufactures and distributes in vitro diagnostic devices focusing on blood coagulation disorders. -
Manager, Quality & Regulatory Consulting GroupOrchid Design Apr 2008 - Oct 2010Mason, Michigan, UsAzary Technologies was acquired by Orchid Design on April 1, 2008. Orchid now offers regulatory and quality services to the medical device industry including auditing, quality system development, training, FDA submissions, international compliance, and regulatory affairs consulting. Between 2000 and 2010 Joseph Azary worked with over 180 medical device companies globally. Orchid Design is part of the Orchid Orthopedic Solutions companies. Orchid Design provides contract engineering, design, testing, and prototype manufacturing activities. -
President / OwnerAzary Technologies Llc Jul 1999 - Apr 2008Owned Azary Technologies LLC, a consulting firm specializing in Regulatory Affairs and Quality Assurance for the medical device industry. Consulting business focusing on quality and regulatory for medical device industry.Services included auditing, quality system development (ISO 13485 and FDA QSR), 510k submissions, training, supplier auditing, regulatory strategy, European MDD compliance, Technical File development, due diligence audits, and quality guidance.Worked with 120 medical device companies around the world including companies in US, Canada, Mexico, France, Italy, United Kingdom, Belgium, and Japan.
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ChairmanAsq - World Headquarters Jul 2002 - Jun 2004Milwaukee, Wi, UsChairman for the ASQ Southern Connecticut Chapter -
Regulatory Affairs CoordinatorFujifilm Medical Systems Jul 1996 - Jul 2000Lexington, Massachusetts, UsQuality Assurance and Regulatory Compliance with FDA regulations, as well as Environmental (EPA), and Health & Safety (OSHA) regulations. Activities included complaint handling, internal auditing, corrective and preventive actions, calibration, document control, training, and member of the Fuji corporate EHS (Environmental, Health & Safety) committee, FDA 510(k)s, MDR reporting, recall coordination, and compliance. Fujifilm Medical Systems is a division of Fuji Photo Film (Japan) and distributes radiography equipment, x-ray film, digital radiography equipment, and medical imaging software and PACS systems. -
Regulatory Affairs Specialist / Regulatory ComplianceJohnson & Johnson Apr 1994 - Jul 1996New Brunswick, Nj, UsRegulatory and Quality including customer complaint investigations, recall coordination, adverse event reporting to government agencies, FDA 510k submissions, auditing, supplier auditing, clean room environmental monitoring, ISO certification, etc.Joint Medical Products was acquired by Johnson & Johnson Professional in 1995. Joint Medical was a manufacturer of orthhopedic implants including hip and knee prostheses. The CT facility closed and I was unable to move to Massachusetts. -
Quality Assurance InvestigatorUs Surgical Corporation (Now Part Of Medtronic) Jun 1991 - Apr 1994United States Surgical Corporation (later became part of Tyco, Covidien and then Medtronic)Handled FDA compliance, customer complaint investigations, adverse event reporting to government agencies, and various compliance activities.
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Analytical ChemistProcter & Gamble Jun 1990 - Aug 1990Cincinnati, Ohio, UsWorked for Richardson-Vicks Division of P&G as an analytical chemist as part of the summer internship program. -
Laboratory AssistantSilver Hill Hospital May 1989 - Aug 1989New Canaan, Ct, UsSummer Internship. Assisted in the hospital laboratory performing urinalysis, drug testing, blood testing, and preparing patients for EKGs.
Joseph Azary Mba Cqa Cmda Education Details
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University Of ConnecticutBiological Science -
Sacred Heart UniversityPublic Health
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Northeastern UniversityMedical Device Regulatory Affairs
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Quinnipiac UniversityHealthcare / Business
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Western Connecticut State UniversityBiology
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Norwalk High SchoolEconomics
Frequently Asked Questions about Joseph Azary Mba Cqa Cmda
What company does Joseph Azary Mba Cqa Cmda work for?
Joseph Azary Mba Cqa Cmda works for Aztech Regulatory & Quality Llc
What is Joseph Azary Mba Cqa Cmda's role at the current company?
Joseph Azary Mba Cqa Cmda's current role is Chief Advisor and Compliance Officer and Co-owner.
What is Joseph Azary Mba Cqa Cmda's email address?
Joseph Azary Mba Cqa Cmda's email address is ja****@****ols.com
What is Joseph Azary Mba Cqa Cmda's direct phone number?
Joseph Azary Mba Cqa Cmda's direct phone number is (203) 294*****
What schools did Joseph Azary Mba Cqa Cmda attend?
Joseph Azary Mba Cqa Cmda attended University Of Connecticut, Sacred Heart University, Northeastern University, Quinnipiac University, Western Connecticut State University, Norwalk High School.
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