Jonathan Armstrong

Jonathan Armstrong Email and Phone Number

Vice President of Quality Assurance and Regulatory Affairs at Critical Innovations LLC @ Critical Innovations LLC
Jonathan Armstrong's Location
Los Angeles, California, United States, United States
Jonathan Armstrong's Contact Details

Jonathan Armstrong work email

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About Jonathan Armstrong

Jonathan Armstrong is a Vice President of Quality Assurance and Regulatory Affairs at Critical Innovations LLC at Critical Innovations LLC. He possess expertise in r&d, medical devices, life sciences, biotechnology, quality assurance and 20 more skills. Colleagues describe him as "I was first introduced to Jon when I joined a sister company to Ceremed over 3 years ago.  Jon has been an extremely valuable resource in regards to everything from training on product manufacturing and inspection processes to maintenance and improvement of every aspect of our quality system.  No matter what Jon has on his plate he is always willing to give advice when asked.  He has the ability to focus on the critical aspects of each situation and present a solution for any issue.  On the rare occasion that he is unfamiliar with the topic at hand, he still finds a way to point you in the right direction. Complimentary to the guidance that Jon provides, is the way in which it is delivered.  Although his knowledge base affords him the ability to speak over the heads of most, it is not his way.  Jon always extends the same level of respect that he is shown, and often more.  These qualities make him an excellent mentor and friend.  He will bring success to any team that he is a part of, not just by the work that he does, but what he brings out in others.", "Jon and I worked closely on all aspects of Ceremed's quality system, from drafting SOPs, to complaint investigations and final inspection/sampling. Jon possesses a tremendous work ethic, knowledge of the standards/regulations and keen eye for detail... key attributes of an effective RA/QA professional. He brings an air of positivity to his team and is always willing to teach others and those more junior, such as myself. Furthermore, Jon leverages his decades of research experience as a framework for his critical thinking and analyses. I am happy to recommend Jon not only as an excellent RA/QA professional, but as my mentor early in my career.", and "I worked with Jon for three years at Ceremed and can say, without any hesitation, that I have never met anyone as dedicated, generous, thoughtful and utterly genuine. Jon plays many vital roles as a senior officer at Ceremed, all of which he approaches with the same level of enthusiasm and diligence. Whether mentoring a green research admin on lab safety and good documentation practices, or serving as an expert advisor to the quality department, or designing complex experiments to show safety and efficacy of a new medical device, Jon maintains an extraordinary commitment to excellence. And he expects (and inspires) nothing short of excellence from those around him. Jon would be a tremendous asset to any company – medical device-related or not – and I cannot recommend him more highly. I feel lucky to count Jon as a colleague, mentor and friend."

Jonathan Armstrong's Current Company Details
Critical Innovations LLC

Critical Innovations Llc

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Vice President of Quality Assurance and Regulatory Affairs at Critical Innovations LLC
Jonathan Armstrong Work Experience Details
  • Critical Innovations Llc
    Vice President Of Quality Assurance And Regulatory Affairs
    Critical Innovations Llc Mar 2023 - Present
    Lawndale, California, Us
    Responsible for authoring, implementation and management of the Quality Management System in accordance with ISO 13485:2016 as well as compliance with all FDA regulatory requirements for medical devices 21 CFR part 820. Also serve as the Management Representative for Critical Innovations and the Safety and Chemical Hygiene Officer.
  • Critical Innovations Llc
    Director Of Quality Assurance And Regulatory Affairs
    Critical Innovations Llc Sep 2018 - Mar 2023
    Lawndale, California, Us
    Responsible for authoring, implementation and management of the Quality Management System in accordance with ISO 13485:2016 as well as compliance with all FDA regulatory requirements for medical devices 21 CFR part 820. Also serve as the Management Representative for Critical Innovations and the Safety and Chemical Hygiene Officer.
  • Ucla School Of Dentistry
    Assistant Researcher
    Ucla School Of Dentistry Jan 2009 - Present
    Los Angeles, Ca, Us
  • Neomatrx
    Principal, Director Of Quality Assurance And Regulatory Affairs
    Neomatrx Mar 2014 - Aug 2018
    Responsible for authoring, implementation and management of the Quality Management System in compliance with ISO 13485:2016 and the FDA's Quality System Regulation 21 CFR Part 820.
  • Ceremed, Inc.
    Senior Scientific Officer, Co-Founder
    Ceremed, Inc. Jan 2003 - Jan 2014
    Los Angeles, Ca, Us
    Ceremed Inc., develops medical devices based on its proprietary alkylene oxide copolymer (AOC) technology.My role as Senior Scientific Officer includes:Direct and conduct scientific research work.Supervise and mentor junior research staff.Perform training - all levels.Select and organize external professional training.Write and implement company policy for research work.Write and complete research protocols and reports.Develop and implement Device Master Records.Complete and manage Design History Files.Establish contact and liaise with external companies, especially with regard to biocompatibility and chemical/functional testing studies.Act as Quality Assurance support for sister-companies:• Assist with Quality System Manual (QSM) policies and procedures• Assist with Document Control (Agile system)• Assist with NCRs and CAPAs• Manage Device Master Records for Product Manufacture• Write manufacturing Work Instructions and Forms• Select and organize external professional training• Manage/Support for sterile product receiving• Train employees (manufacturing, quality, sales)
  • Ceremed, Inc.
    Quality Assurance Manager
    Ceremed, Inc. Jan 2003 - Feb 2008
    Los Angeles, Ca, Us
    • Management Representative• Wrote Quality System Manual (QSM) policies and procedures• Managed the implementation of the QSM• Maintained the QSM• Responsible for Document Control• Managed and implemented the Corrective Action/Preventive Action system.• Performed internal audits• Wrote QSM and manufacturing Work Instructions and Forms• Performed in-process manufacturing Quality inspections• Managed and prepared Device History Records• Managed and maintained the Approved Vendor List• Performed audits of vendors• Managed and performed product receiving and receiving inspection• Managed inventory (final product and raw materials)• Trained employees (manufacturing, quality, sales)• Managed external audits (BSi, California State)• Managed Design Dossier and Technical files• Involved in Design Control (various roles beyond Quality regarding product development)
  • University Of Southern California
    Assistant Professor
    University Of Southern California 2001 - Apr 2009
    Los Angeles, Ca, Us
  • University Of Southern California
    Visiting Assistant Professor
    University Of Southern California Jan 2000 - Jan 2001
    Los Angeles, Ca, Us
  • University Of Southern California
    Senior Research Associate
    University Of Southern California Jun 1998 - Dec 1999
    Los Angeles, Ca, Us
  • University Of Southern California
    Research Scholar
    University Of Southern California Oct 1993 - May 1998
    Los Angeles, Ca, Us

Jonathan Armstrong Skills

R&d Medical Devices Life Sciences Biotechnology Quality Assurance Validation Biochemistry Lifesciences Gmp Science Fda Molecular Biology Sop Polymers Glp Drug Discovery Document Management Technology Transfer Vendor Management U.s. Food And Drug Administration Polymer Modification Qsm Implementation Effective Capa Management Document Control Internal/vendor Auditor

Jonathan Armstrong Education Details

  • University Of Greenwich
    University Of Greenwich
    Physical Chemistry
  • Thames Polytechnic
    Thames Polytechnic
    Applied Chemistry

Frequently Asked Questions about Jonathan Armstrong

What company does Jonathan Armstrong work for?

Jonathan Armstrong works for Critical Innovations Llc

What is Jonathan Armstrong's role at the current company?

Jonathan Armstrong's current role is Vice President of Quality Assurance and Regulatory Affairs at Critical Innovations LLC.

What is Jonathan Armstrong's email address?

Jonathan Armstrong's email address is jo****@****ail.com

What is Jonathan Armstrong's direct phone number?

Jonathan Armstrong's direct phone number is (310) 825*****

What schools did Jonathan Armstrong attend?

Jonathan Armstrong attended University Of Greenwich, Thames Polytechnic.

What skills is Jonathan Armstrong known for?

Jonathan Armstrong has skills like R&d, Medical Devices, Life Sciences, Biotechnology, Quality Assurance, Validation, Biochemistry, Lifesciences, Gmp, Science, Fda, Molecular Biology.

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