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Email Verified Kenneth D
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Member since March 26, 2019
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Quality For MedTech

  • $150.00 - $200.00 / hr
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Professional medical devices’ leader with twenty plus years experience in areas including heart valves, cardiopulmonary, neuromodulation, TAVI, TMVR, heart failure, and dental. Strong quality, regulatory, and new product development skills with global responsibilities. Experienced in Quality Engineering and Operations, Quality Systems, Lean Manufacturing principles, cGMP, cGLP, spanning New Product Development and continued operations to include, design, development and documentation, risk management, auditing, audit management, regulatory bodies management, receiving inspection, calibrations, preventative maintenance and training, product release, post market surveillance, recalls, CAPA, NCR, complaints, sterility assurance, biotoxicity and chemical acceptability. Strong background in quality systems principles and regulations, including QSRs (21CFR820, 21CFR58, ISO13485, ISO10993), CMDR, MDD/MDR, TGA and JPAL. Hands on management of onsite regulatory audits by FDA, TUV, BSI, DEKRA, TGA, PMDA, Korean FDA, SFDA, ANVISA. Ability to work across cross functional teams at all levels and global sites to accomplish key operating drivers. Proven leadership, accountability, results oriented with excellent communication and strong project management skills. Strong finance and budget management experience. Invited speaker and thought leader at several Medical device forums and summits. Former adviser to the Dean, College of NSM and adjunct faculty on medical device courses at California State University Fullerton.

Experience

VP, Quality Engineering

  •  QA Medi Co
  •  Aug 2018 - Present

• Responsible for global organization encompassing multiple product development, manufacturing, product distribution/support sites and laboratories worldwide (sites include Houston, Vancouver, Saluggia, Mirandola, Minneapolis, Arvada, Pittsburgh, Miami, Melbourne, Sao Paulo and Munich)
• Provide overall strategic direction and operational coordination of activities for global New Product Development Quality Assurance, Quality Engineering, and Quality Operations groups to ensure compliance with global regulations and alignment with company objectives and Quality Standards
• Responsible for evaluating and implementing continuous improvement processes to improve operational efficiency and systems aligned with FDA and global regulatory requirements.
• Set the strategies for establishment of a global quality organization to support the product lifecycle management from concept to product realization followed by post market surveillance.

Sr. Director, Quality

  •  Lifesciences Inc.
  •  Mar 2017 - Dec 2018

Areas of responsibilities covered Quality Engineering, Laboratories and Product Development Practices

• Quality Engineering Heart Valves
• Overall site responsibilities for relocating laboratories to new location implementing lean principles across global laboratories
• Develop and administer budgets, plans and performance requirements linked to the departments
• Organize, direct, and provide guidance to assure a technical climate of excellence throughout global laboratory operations (Salt Lake City USA, Switzerland, Puerto Rico, Dominican Republic, and Singapore)
• Ensure all manufactured products meets corporate and global regulatory requirements
• Support Discovery, Research and Development, Global Manufacturing Operations and Regulatory disciplines, by providing technical expertise and support in the areas of Design and Development, Verification and Validation, Product release, Post market surveillance, recalls, risk management, Biocompatibility, Toxicology (Cell Culture, Gene and small animal), Tissue Safety, Sterilization, Clean room Design, Monitoring and Maintenance, Product and Employee safety testing.
• Responsible for evaluating, establishing and maintaining efficient, state of the art programs in the above disciplines, maintaining global regulatory compliance, planning and managing budgets in excess of $8.3 MM, staffing and global talent development
• Provide technical expertise to all global manufacturing plants for trouble shooting, method development, validations, etc.

Project Leader, R&D

  •  Health Tech Materials Co.
  •  Sep 2017 - Sep 2016

• Product development of biomaterials & class II / III medical devices, managed group budget and timeline to meet project and business objectives. Plan and manage laboratory budgets and operations.
• Complied with FDA/ISO guidelines, 510(k), PMA approval, cGMP & cGLP.
• Develop protocol and methods for product QA, assays, test methods, manufacturing protocol, reviewed data and recommended procedures. Assisted in designing clinical studies, interpreted data and presented it to the board of directors. Managed documentation for FDA approval of laboratory.
• Liaison with Quality and Regulatory on support issues, review and approve documentation. Technical Advisor for Sales and Marketing. Liaison with outside research organizations on research (Toxicology) studies. Designed, synthesized and characterized novel monomers for use in medical devices.
• Lab scale, pilot plant and production scale manufacturing

Education

B.S. Chemical Engineering

  •  University of Southern California
  •   - Mar 2021