Scott Johnson Pe Email & Phone Number

Risk Management, Quality and Engineering Services within the Life Sciences

Minneapolis, Minnesota, US

Member of the Board of Directors (NASDAQ: PETV) and member of the compensation committee and manufacturing task force for novel biomedical material commercialized within a veterinary combination product (prefilled syringe for lameness joint injection targeting equine, canine, and feline).

Thousand Oaks, CA, US

Advisor and program leader of a dozen external SMEs focused on the combination product quality elements of risk management, human factors and design controls. Product DHFs were reviewed and enhancements to further support the documentation were itemized. SOPs were reviewed and enhancements were authored and encouraged for implementation. Human Factors.

Kerikeri, Northland, NZ

MA&TC Business Group level leader authoring the initial post market surveillance plans and reports for all Risk Classes of product. Also drove the improvement of existing risk management hazard analysis trace matrices to provide necessary EU MDR post market surveillance data required in the PSURs, PMSRs and clinical evaluation reports.

Amsterdam, Noord-Holland, NL

Advisor to the defibrillator design change review board. Focus was on changes based on safety, CAPA and assurance of the supply of components. Contributing factors included the competing interests of a consent decree, new FDA expectations of PMA submission for defibrillator products, and business unit mergers generating an environment with the potential of.

Warsaw, Indiana, US

Consultant role for PMA development of all documents demonstrating an established design for the medical devices used for transplant of stem cells. Performed gap assessment of current DHF, risk files and regulatory standards. Authored acceptance criteria to control supplier quality and future manufacturing. Led device master record compilation and initial.

Deerfield, Illinois, US

Consultant role included flexible container closure listening system / value stream gap analysis with emphasis on product distribution methods, packaging, internal and third party transportation vendors. Consultant role also included Quality Systems Improvement Project focused on essential requirements data collection, consistent multi-site manufacturing.

Lake Forest, IL, US

Consultant functions included authoring pharmaceutical combination product device constituent design transfer plans, compiling device master record index for multiple injector configurations, gap assessments and technology transfer final reports and coordination of multiple-site resources.

Lake Forest, IL, US

Consultant functions included combination product device constituent design history file audit, gap assessment, generating DMR Index, authoring verification by analysis reports, remediation prioritization and document generation for Notified Body CE marking compliance and re-certification.

Lake Forest, IL, US

Consultant functions included risk files document review, process mapping, gap assessment, FMEA content generation and tracing strategy. Scope includes the 3D (Differentiated Drug Delivery) product families of generic injectable pharmaceuticals and consumable administration sets. Internal compliance audit of combination products with regard to 21 CFR Part.

Greenville, South Carolina, US

Consultant functions included conducting pharmaceutical supply chain audits and medical device start-up company ISO 13485 quality system audits. Authored audit reports and generated feedback on the most cost effective strategies for the remediation of compliance gaps and specific engineering challenges.

Warsaw, Indiana, US

Consultant functions included the leading of engineering consultants (22 on-site and remote) and Zimmer employees through remediation of FDA 483 observations regarding manufacturing verification processes, measurement tools, automated data collection (MeasureLink and Infinity QS evaluations) and future transformation of the quality system to a dynamic risk.

St. Paul, Minnesota, US

Consultant functions included leading FDA warning letter quality system remediation and software validation projects for implantable neuromodulation products and custom automated test systems. Liaison with Quality, R&D and Operations. Led validation of the facility environmental controls and monitoring systems validation.Completed a division-wide systemic.

Eden Prairie, MN, US

Consultant functions included leading engineering programs for custom automated surface enhancement of catheters and guide wires. Developed processes and capital equipment solutions for lubricious and antimicrobial surface modification. Delivered pharmaceutical quality systems guidance for producing combined medical devices with active pharmaceutical.

Miami Lakes, FL, US

Consultant functions included leading 16 consulting engineers and technicians to advance the product development, manufacturing process and quality systems for NEVO drug-filled stent delivery system catheters.

Aberdeen, Scotland, GB

Program Manager of multi-discipline professional engineering consulting team. Leader of projects for the design and construction of Dow industrial manufacturing facilities. Identified and maintained large facility project scope, schedule, budget, contracts, invoicing and financial collections. Interacted with Dow personnel, other consultants and on-site.

Marlborough, MA, US

Consultant functions included leading the initiative to design, validate and comply with GMP and FDA requirements (including 21 CFR Part 11, electronic records). The result of the project was upgraded and newly designed automated capital equipment utilizing automated data collection. The medical device clean room project resulted in a 30% capacity increase.

Led verification and validation of capital equipment and software. Designed and built proof-of-concept models for intellectual property securement. Engagements included an operating room surgical tool, a chiropractic tool and a residential food processing machine. Lead the development of all linear piston pump systems. Led the interaction with EPA and UL.

Managed all engineering aspects of proprietary medical device process development, machine design, prototyping, manufacturing, testing and packaging projects.

Alexandria, MN, US

Designed prototype conveyorized packaging equipment. Developed and documented PLC ladder logic, schematics, wiring diagrams and generated material cut lists. Programmed M and G code for CNC mills. Vendor and client liaison, on-site capital equipment commissioning and warranty service calls.