John Daley Email and Phone Number
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With over 20 years of experience in the medical device, pharmaceutical, and consumer electronics industries, I am a senior vice president and chief quality officer at Juul Labs, the first and only vaping company to obtain ISO 13485 certification. While at JUUL I transitioned them from a consumer electronics to a certified medical device company, meeting the highest standards of quality, safety, and compliance in a highly regulated market.I have held numerous board-level positions and led global teams at industry leaders such as Johnson & Johnson, IBM Watson Health, and Boston Scientific. I have extensive experience in managing and remediating FDA, ISO, and other audits, as well as securing regulatory approvals and compliance for various products and services. I have also been involved in multiple business development deals, ranging from the low millions to the billions. I have a hands-on understanding of AI and machine learning, and how to validate and regulate them in the health care industry. I possess a BSME and an MBA, and have published in the Journal of Validation Technology. I am passionate about crafting and executing strategies that deliver results, innovation, and value for both customers and stakeholders.
Compliance Architects®
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- compliancearchitects.com
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Vp -Sme Medical DevicesCompliance Architects®Edgartown, Ma, Us
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Vp-Sme Medical DevicesCompliance Architects® Jun 2024 - PresentMassachusetts, United StatesI am thrilled to be the new VP-SME at Compliance Architects, a full-service consulting firm serving FDA regulated industries.In this position, I'll be working tirelessly to help our clients find solutions for any and all needs they may have.
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Quality And Regulatory LeaderSelf-Employed Jan 2024 - Present
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Senior Vice President - Chief Quality OfficerJuul Labs Aug 2019 - Sep 2023San Francisco Bay AreaEnsured JUUL transitioned from a consumer electronics to a certified medical device company.-Obtained ISO 13485 certification for the JUUL Quality system the first and only vaping company to obtain such credentials-Worked with our tier 1 suppliers to ensure they obtained and maintained their ISO 13485 certifications as well.-Was a hands-on cultural change agent as JUUL transitioned to a regulated market -
Vice President Quality Assurance, Regulatory Affairs, Privacy And SecurityIbm Watson Health May 2016 - Aug 2019Cambridge, MaChief Quality and Regulator Officer-Was responsible for creating and executing the "software as a medical device (SAMD)" strategy for all of IBM-Secured ISO 13485 and ISO 9001 certification for the division. This was a first ever for IBM-Worked with extensively with FDA and international regulators to help them both understand and regulate machine learning in the health care industry.-Oversaw a hybrid and globally dispersed workforce and ensured on-time delivery of software and services to various clients-Gained a hands on understanding of AI/Machine learning, how it works, how to validate it, and how to regulate it.-Worked to prepare IBM for their first ever PMA submission for an AI breast cancer screening tool-Ensured Watson for Oncology was globally compliant with all relevant international regulations.
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Multi-Site Vp - Endoscopy, Urology, And Women'S HealthBoston Scientific May 2011 - May 2016Greater BostonManagement Board Member for the Endoscopy and Urology and Women's Health divisions of Boston Scientific.-Responsible for crafting and executing the Quality business strategies for both divisions-Oversaw a global plant network-Responsible for all all plant and divisional complaint activities including design and manufacturing-Integral part of the Business Development Function including the $1.6B purchase of American Medical Systems. -
Vp Qa - International, Distribution And Supply ChainBoston Scientific Mar 2007 - May 2011Greater BostonHelped remediate a Corporate Warning Letter.Ensured the global distribution system was compliant with all relevant regulations.Assumed responsibility for all international compliance.Received zero observations from any of our warning letter follow-up inspections.
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Executive DirectorCordis, A Johnson & Johnson Company 2004 - 2007QA Board Member for Cordis Endoscopy and Cordis NeurovascularIntegral part of the management team that was brought in to resolve the corporate warning letter. -
Executive DirectorCordis Neurovascular Inc., A Johnson & Johnson Co. 2004 - 2007QA Board member.
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Executive DirectorJohnson & Johnson 1999 - 2007 -
Director - Quality EngineeringLifescan 1999 - 2001Had responsibility for Software Quality, Design Assurance, Document Control, Statistical Engineering and Process Validation
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Senior EngineerDavol 1992 - 1996
John Daley Skills
John Daley Education Details
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Mechanical Engineering
Frequently Asked Questions about John Daley
What company does John Daley work for?
John Daley works for Compliance Architects®
What is John Daley's role at the current company?
John Daley's current role is VP -SME Medical Devices.
What is John Daley's email address?
John Daley's email address is ja****@****ley.com
What is John Daley's direct phone number?
John Daley's direct phone number is +150825*****
What schools did John Daley attend?
John Daley attended State University Of New York At Albany, University Of Rhode Island.
What skills is John Daley known for?
John Daley has skills like Iso 13485, Fda, Quality System, Medical Devices, Design Control, Capa, Validation, V&v, Dmaic, Design Of Experiments, Quality Assurance, Iso 14971.
Who are John Daley's colleagues?
John Daley's colleagues are Pedro A. Martinez-Rivera, Kenneth Ray, Joanne Garvey, Michelle Marchok, Gerard Appert.
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John Daley
Ashburn, Va6msn.com, rediffmail.com, aol.com, ibm.com, gmail.com, gmail.com2 +170392XXXXX
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John Daley
Mission Command Information Systems Planning Officer | Us Army Captain | Global War On Terror - Operation Inherent Resolve VeteranBoston, Ma -
John Daley
Product Management Leader With Equal Parts Analytical Business Sense And Technical Savvy, Who Launches And Delivers Customer-Ready Products For Startups And Fortune 500 Companies.Arlington, Va2gmail.com, neustar.biz7 +170328XXXXX
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John Daley
Atlanta Metropolitan Area5hotmail.com, goarmy.com, gmail.com, eaton.com, eaton.com1 +125442XXXXX
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