Jonathan Watkins

Jonathan Watkins Email and Phone Number

Director, Quality Systems at ACIST Medical Systems / Bracco Medical Technologies @ Bracco Medical Technologies
Jonathan Watkins's Location
Eden Prairie, Minnesota, United States, United States
Jonathan Watkins's Contact Details

Jonathan Watkins work email

Jonathan Watkins personal email

n/a

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About Jonathan Watkins

Professional Experience:-Medical Device Quality Management experience with Quality Systems, Post-Market Surveillance, Corrections/Removals/Recall, and Supplier Quality management.-Fluent with worldwide medical device quality standards and regulations, including ISO 13485:2016, FDA QSR, MDD/MDR, MDSAP, and others-Medical Device quality engineering expertise in the field of Cardiac Rhythm Management and cardiovascular diagnostic technologies (including contrast imaging systems for cardiovascular angiography and High Definition IVUS)-Electronic components customer quality engineering (operations and development areas) Education:-MBA-Chemical EngineeringCertifications/Training:-ASQ Certified Quality Engineer (CQE)-ISO 13485 Lead AuditorSpecialties: - Medical Device Quality Systems Management, Supplier Quality Management, Supplier Development, Supply Chain Risk Management, Supplier Quality Audits, Quality Management / MDSAP audit lead, Quality Inspection/Quality Control, Post-Market Surveillance, Recall strategy and management

Jonathan Watkins's Current Company Details
Bracco Medical Technologies

Bracco Medical Technologies

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Director, Quality Systems at ACIST Medical Systems / Bracco Medical Technologies
Jonathan Watkins Work Experience Details
  • Bracco Medical Technologies
    Director Of Global Quality Assurance
    Bracco Medical Technologies Dec 2021 - Present
    United States
    • Led upgrade and implementation of EU MDR-compliant Quality System. • Led successful expansion of global Quality System to cover multiple legal manufacturer sites. • Responsible for overall development, implementation, and maintenance of the Global Quality Management System (QMS). • Manages compliance to FDA QSR, EU MDD, EU MDR, ISO 13485:2016 and other Global regulations and international standards. • Enforces the global quality system requirements and ensures its harmonization with other ACIST and Bracco business entities.• Manages internal and external audit processes, including communication with FDA, Notified Bodies, and other regulatory agencies.• Leads team in support of all Quality Management System functions, including Document Control, Training and Development, Software Quality Assurance, CAPA, and Internal Audit.• Leads Post-Market Surveillance team, including support for Recall and Field Action actiivities
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  • Acist Medical Systems
    Sr. Manager, Quality Systems
    Acist Medical Systems Jul 2018 - Dec 2021
    Eden Prairie, Mn
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  • Acist Medical Systems
    Manager Of Receiving Inspection And Supplier Quality
    Acist Medical Systems Jun 2015 - Jul 2018
    Eden Prairie, Mn
    • Manage Receiving Inspection lab, including team of Quality Technicians supporting manufacture of medical device capital equipment for cardiovascular imaging.• Lead/coach Supplier and Product Quality Engineers on supplier quality, supplier development, and supplier risk management initiatives.• Drive improvement and corrective action in the quality of implantable Medical Device components sourced from outside vendors• Audit existing suppliers for compliance to ISO 13485 and 21 CFR 820 Quality System requirements and monitor implementation of corrective action for any findings that are identified• Maintain the Approved Vendor List and negotiate contractual Supplier Quality Agreements with vendors• Monitor supplier performance, communicate issues to suppliers, and execute activities to further develop supplier performance and capability• Generate and maintain incoming inspection procedures, analyze incoming material defects, and disposition and drive corrective actions • Assess potential new suppliers for technical, quality and manufacturing capabilities
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  • Acist Medical Systems
    Sr. Supplier Quality Engineer
    Acist Medical Systems Oct 2013 - May 2015
    Eden Prairie, Mn
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  • Boston Scientific
    Senior Supplier Quality Engineer
    Boston Scientific Apr 2009 - Oct 2013
    St. Paul, Mn
    • Drive improvement and corrective action in the quality of implantable Medical Device components sourced from outside vendors• Audit existing suppliers for compliance to ISO 13485 and 21 CFR 820 Quality System requirements and monitor implementation of corrective action for any findings that are identified• Maintain the Approved Vendor List and negotiate contractual Supplier Quality Agreements with vendors• Monitor supplier performance, communicate issues to suppliers, and execute activities to further develop supplier performance and capability• Generate and maintain incoming inspection procedures, analyze incoming material defects, and disposition and drive corrective actions • Assess potential new suppliers for technical, quality and manufacturing capabilities
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  • Hutchinson Technology, Inc.
    Product Development Quality Engineer
    Hutchinson Technology, Inc. Aug 2006 - Apr 2009
    Hutchinson, Mn
    • Lead quality-related development activities such as writing process control plans, deploying statistical process control (SPC), establishing inspection criteria, and performing product reliability investigations, and leading failure mode effects analysis (FMEA) teams• Directed team engineers and technicians to meet development quality goals, implemented preventive or corrective actions, and maintained alignment to the corporate quality philosophy• Negotiated customer quality requirements such as visual criteria, cleanliness specifications, and design specifications, and represented the voice of the customer throughout the product development life cycle• Published customer qualification data throughout the various stages of product development• Collaborated with staff in Asia to quickly resolve customer quality issues within specified timeline goals, including qualification and validation of closed-loop corrective actions
  • Hutchinson Technology, Inc.
    Customer Quality Engineer
    Hutchinson Technology, Inc. Feb 2002 - Aug 2006
    Hutchinson, Mn
    • Provided direct 24-7 customer quality support in the focus factory• Implemented sampling plans, in-process audits, special measurement plans, and disposition of non-conforming product• Collaborated with customers to resolve engineering and quality concerns for design-for-manufacturability, visual criteria, design specifications, cleanliness specifications and measurement plans• Provided leadership to resolve customer quality issues through failure analysis, root cause investigation, corrective action deployment and validation for effectiveness• Supported business unit through strategic planning, customer visits to Thailand, China, Japan and Philippines, and quarterly updates to the executive team
  • Hutchinson Technology, Inc.
    Chemical Engineer
    Hutchinson Technology, Inc. Jun 1999 - Sep 2001
    Hutchinson, Mn
    • Provided manufacturing engineering support for flex circuit-like disk drive components• Improved process yields by utilizing Design Of Experiment, ANOVA, control charting and measurement systems analysis for resist coat, expose, and develop processes• Directed manufacturing technicians in development and yield-improvement testing activities

Jonathan Watkins Skills

Design Of Experiments Quality System Spc Fmea Iso 13485 Root Cause Analysis Manufacturing Capa Supplier Quality Medical Devices Validation Failure Analysis Cqe Process Engineering Lean Manufacturing Supplier Quality Management Gage R&r Quality Auditing Supplier Evaluation

Jonathan Watkins Education Details

Frequently Asked Questions about Jonathan Watkins

What company does Jonathan Watkins work for?

Jonathan Watkins works for Bracco Medical Technologies

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

Jonathan Watkins's current role is Director, Quality Systems at ACIST Medical Systems / Bracco Medical Technologies.

What is Jonathan Watkins's email address?

Jonathan Watkins's email address is jo****@****ist.com

What is Jonathan Watkins's direct phone number?

Jonathan Watkins's direct phone number is +165185*****

What schools did Jonathan Watkins attend?

Jonathan Watkins attended Bethel University, University Of Minnesota, Bethel University, Denfeld High School.

What are some of Jonathan Watkins's interests?

Jonathan Watkins has interest in Distance Running, Camping, Travel, Canoeing.

What skills is Jonathan Watkins known for?

Jonathan Watkins has skills like Design Of Experiments, Quality System, Spc, Fmea, Iso 13485, Root Cause Analysis, Manufacturing, Capa, Supplier Quality, Medical Devices, Validation, Failure Analysis.

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