Scott Johnson Pe's Location
Incline Village, Nevada, United States, United States
Scott Johnson Pe's Contact Details
Scott Johnson Pe work email
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Scott Johnson Pe personal email
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About Scott Johnson Pe
*Mr. Johnson applies extensive Life Sciences industry knowledge to risk files, quality systems, design controls, cross-functional business unit program success, technology integration, supply chain partnerships and intellectual property.*Program Manager with proven success in leading compliance and remediation efforts for government regulated product development, design history files, test method validation and quality system remediation.*Accomplishments within product design, technology integration, design transfer to production, audit and remediation, production capacity increases, facility expansions and decommissioning, CAPA leadership, process flow mapping, hazard analysis and post-market surveillance. *Thorough range of engineering staff leadership, capital project commissioning and quality systems experience relating to software driven electro-mechanical and consumable medical devices, pharmaceuticals and combination products.*Compliance activities regarding: FDA (21 CFR Part 4, 11, 58, 210, 211, 820) ISO (9001, 13485, 14971, 17025, 31000) IEC (60601, 62304, 62366, 60050)EPA (Section 608 and 609)*Critical thinker with exceptional communication skills, both oral and written.*Sustains a culture that is under control, ethical, profitable, positive and creative. "First tell the truth, then give your opinion."
Scott Johnson Pe's Current Company Details
Stratego, Inc.
Solving risk management, quality and engineering challenges in the Life Sciences
Scott Johnson Pe Work Experience Details
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PresidentStratego, Inc. Dec 2012 - PresentRisk Management, Quality and Engineering Services within the Life Sciences
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Professional Engineering AdvisorStratego, Inc. Aug 2003 - Present
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Member, Board Of DirectorsPetvivo Holdings Inc Jun 2019 - Nov 2023Minneapolis, Minnesota, UsMember 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). -
Platform Combination Product Quality LeaderAmgen Sep 2021 - Jun 2022Thousand Oaks, Ca, UsAdvisor 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 process flow was clarified and organizational restructuring was also presented for consideration. Leadership liaison efforts included weekly meetings with internal and external (Sidley-Austin) corporate legal counsel. -
Eu Mdr Core Team Lead - Post Market Surveillance And Risk ManagementPhillips Healthcare Mar 2019 - Mar 2020Kerikeri, Northland, NzMA&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. -
Design Controls And Risk Management Advisor - Ma & TcPhilips Jan 2017 - Dec 2018Amsterdam, Noord-Holland, NlAdvisor 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 multiple quality systems.Deliverables included developing a medical device risk assessment process, similar to FDA QSIT. This was capable of auditing end to end risk file documents and company production, supplier and listening system processes. Promoted the concept of linking dFMEA product failures to patient harm and provided multi-level system design requirements and testing trace matrix strategy including labeling and packaging. -
Project Manager, Biologics Pma ReadinessZimmer Biomet Jan 2016 - Oct 2016Warsaw, Indiana, UsConsultant 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 design transfer process. Led cross-functional PMA Steering Committee Meetings. -
Global Pmo Project ManagerBaxter International Inc. Jun 2015 - Dec 2015Deerfield, Illinois, UsConsultant 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 metrics and presentation of data analytics for senior leadership. Products and subjects in scope included remediation of multiple flexible container closures, requiring reductions in particulate matter and improved sealing integrity. -
Combination Product Design Transfer ConsultantHospira Jan 2015 - Jun 2015Lake Forest, Il, UsConsultant 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. -
Quality System Specialist - Combination ProductsHospira Aug 2013 - Dec 2014Lake Forest, Il, UsConsultant 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.
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Risk File Remediation EngineerHospira Jan 2013 - Jul 2013Lake Forest, Il, UsConsultant 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 4, 210, 211, 820 and ISO 13485, 14971 (2012).
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Quality Systems Compliance AuditorMedpoint Jul 2012 - Dec 2012Greenville, South Carolina, UsConsultant 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. -
Program ManagerZimmer Mar 2012 - Jul 2012Warsaw, Indiana, UsConsultant 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 management environment with the goal of Operational Excellence.
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Program ManagerSjm - Neuromodulation Jul 2011 - Feb 2012St. Paul, Minnesota, UsConsultant 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 test method validation cultural shift. This included the creation of a multiple-site validated test methods library and revision of the necessary SOP, work instruction, supporting templates and authoring of a live training curriculum and testing for over 250 people. -
Program ManagerHarland Medical Systems, Inc. Mar 2010 - Apr 2011Eden Prairie, Mn, UsConsultant 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 ingredients. -
Engineering Team LeaderCordis (Johnson & Johnson) Jun 2009 - Dec 2009Miami Lakes, Fl, UsConsultant 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. -
Program ManagerAmec Engineering Apr 2008 - Jan 2009Aberdeen, Scotland, GbProgram 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 construction project manager. -
Project Manager - Production Equipment ImprovementsBoston Scientific Aug 2005 - Jan 2008Marlborough, Ma, UsConsultant 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 in throughput for assembly, testing and packaging of coronary guide catheters. Multiple facilities were located in Mexico and the US. -
Principal - Engineering ConsultingBeyond Engineering Jun 1994 - Aug 2005Led 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 management regarding test protocols, requirements and labeling. Liaison with corporate scientists, buyers, technicians and upper management of customers. Led sales efforts to integrate these systems.
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Engineering Team LeaderScimed (Boston Scientific) May 1989 - Jun 1994Managed all engineering aspects of proprietary medical device process development, machine design, prototyping, manufacturing, testing and packaging projects.
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EngineerMassman Companies Jun 1988 - Mar 1989Alexandria, Mn, UsDesigned 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.
Scott Johnson Pe Skills
Quality System
Validation
Iso 13485
Medical Devices
Fda
Risk Management
R&d
21 Cfr Part 11
Manufacturing
Capa
Program Management
Auditing
V&v
Fmea
Iso
Product Development
Design Control
Testing
Lean Manufacturing
Quality Auditing
Design Of Experiments
Cross Functional Team Leadership
Pma Readiness
Biomedical Engineering
Combination Products
Test Method Validation
Design Transfer
Technology Transfer
Project Management
Iso 14971
Risk File
Machine Design
Compliance Remediation
Processes Development
Process Mapping
U.s. Food And Drug Administration
Verification And Validation
Corrective And Preventive Action
Scott Johnson Pe Education Details
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North Dakota State UniversityPolymers & Coatings Emphasis
Frequently Asked Questions about Scott Johnson Pe
What company does Scott Johnson Pe work for?
Scott Johnson Pe works for Stratego, Inc.
What is Scott Johnson Pe's role at the current company?
Scott Johnson Pe's current role is Solving risk management, quality and engineering challenges in the Life Sciences.
What is Scott Johnson Pe's email address?
Scott Johnson Pe's email address is sc****@****ail.com
What schools did Scott Johnson Pe attend?
Scott Johnson Pe attended North Dakota State University.
What are some of Scott Johnson Pe's interests?
Scott Johnson Pe has interest in Isla Mujeres, Kite Boarding, Trail Running, Boating, Kickboxing, Beach Volleyball, See Less, See 3, Hiking, Windsurfing.
What skills is Scott Johnson Pe known for?
Scott Johnson Pe has skills like Quality System, Validation, Iso 13485, Medical Devices, Fda, Risk Management, R&d, 21 Cfr Part 11, Manufacturing, Capa, Program Management, Auditing.
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