Mark Swanson's Location
Becker, Minnesota, United States, United States
Mark Swanson's Contact Details
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About Mark Swanson
Self-starting, strategic thinker recognized as a subject matter expert in Medical Device Quality Management Systems including Risk Management, Design and Development, Management Responsibilities and Improvement. Specific experience includes audit and submissions to comply with US QSR (21CFR820), ISO 13485, Canadian Medical Device Regulations (CMDR/CMDCAS), Medical Device Directive (MDD), In-vitro Diagnostic Directive (IVDD), Japan Pharmaceutical Affairs Law (JPAL), Therapeutic Goods Act (TGA), Brazilian regulations (ANVISA) including the Medical Device Single Audit Program (MDSAP). Extensive career experience throughout the product life cycle for all classes of medical devices, biologics, drug combination devices as well as in vitro diagnostics from concept through development to product release and post-market support. Solid reputation for maintaining a firm grasp of project details while also keeping the big picture in focus.Quality Management Systems--Quality Management Systems expert participating member with ISO TC210, WG1 on next revision of ISO13485 as well as ISO 9000 and 9001. Recognized subject matter expert for Medical Device Product Risk Management (ISO 14971). Called on by senior management to integrate the quality management systems of acquisitions and remediate notified body audit major non-conformance as well as provide direct support and auditor interface for numerous audit/inspections (including FDA, EU certification/notified bodies and other competent authorities (ANVISA, TGA, etc.).Operations--Served as the area quality assurance leader and a site mentor for the quality group responsibilities including product quality and Corrective/Preventive Action (CAPA) program. Supervised quality group responsibilities for manufacturing areas with several direct and indirect reports. Design/Development--Lead Design Assurance team member from concept through design development and into post market support for several next generation products and new product lines. Participated in supplier selection and led audits for supplier qualification.
Mark Swanson Work Experience Details
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Founding PartnerQrx Partners Jul 2020 - PresentMinneapolis, Minnesota, UsPartnership consulting firm providing quality systems and management consulting to small & medium companies (<$1B in revenue) in both medical device (ISO 13485) and other industries (ISO 9001) as well as provide consultants to other firms for projects including audit, gap analysis, remediation and training course instruction. Steve Gompertz, Jackie Torfin and I want to ensure small and medium sized companies have the expertise available to them that large companies take for granted. We are here for you! -
Chair/Clerk/DirectorBecker Board Of Education Jan 2011 - Dec 2022One of 6 board members setting the direction of education for over 1200 students in Pre-K through 12th grades. Worked with new Superintendent to establish policy governance model for board work. • Served as board representative to Technology Committee during initial implementation of 1:1 program to issue iPads to grades 9–12, leading to significant cost savings on text books and improved outcomes in student achievement.• Successfully completed teacher contract and administration negotiations for several 2 year contracts. Kept staff expenses within budget, obtained important agreements for subsequent year negotiations while working to meet needs of union negotiators.• Recognized for leading effort to improve organizational excellence including creation of new district-wide vision statement and goal setting process. Ensured appropriate stakeholder input and set tone of using vision statement and goals to drive board decisions.
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President/Principal ConsultantH & M Consulting Group Jun 2012 - Jul 2020Independent consulting firm providing quality systems and management consulting to small companies (<100 employees) in both medical device (ISO 13485) and other industries (ISO 9001) as well as provide consultants to other firms for projects including audit, gap analysis, remediation and training course instruction.—Design Control Remediation—Provided direct support for Design History File (DHF) formation and audit including all aspects of Design development, risk management, and verification/ validation activities. Specific target markets for US (CFR), EU (MDR/IVDR), Japan (JPAL), China (SFDA), Australia (TGA), Canada (CMDR) and Brazil (ANVISA) through MDSAP—Creation of Systems—Managed projects for creation and update of key quality systems including quality manual, design development processes, supplier management, complaint handling & event reporting, and risk management processes for small and large medical device companies—Technical Leader—Active member of ISO TC210 for the update of ISO 13485 and co-lead for handbook and WG6 (post-market surveillance). Instructor for MN ASQ courses for Certified Manager of Quality/Organizational Excellence, Certified Quality Engineer and Certified Biomedical Auditor—Project Leadership—Provided project leadership and support through external consulting firms. Completed project to address internal audit gaps for clients. Led effort to integrate OEM supplied product for distribution and reprocessing. —Expert Witness Testimony—provided supporting testimony for cardiac medical devices. Recommended by Expert Institute—Lead Auditor and Assessor—Provided client companies with direction for risk management and auditing programs to ensure ongoing conformance for ISO 9001, ISO 13485 and other medical device requirements—American Society for Quality (ASQ) designation as Certified Manager of Quality/Operational Excellence (CMQ/OE), Certified Quality Engineer (CQE) and Certified Biomedical Auditor (CBA)
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Contracted Principal ConsultantRegulatory And Quality Solutions Llc (R&Q) Jan 2018 - Oct 2019Monroeville, Pa, UsProvide consulting services to medical device companies. -
Executive Director, Intel & Technical ExcellenceRegulatory And Quality Solutions Llc (R&Q) Apr 2017 - Jan 2018Monroeville, Pa, UsGathering regulatory and quality systems intelligence and technical information for sharing to other consultants within the organization.Provide direct consulting support to client organizations.Extensive research into new European Medical Device Regulation (EU MDR) and In vitro Diagnostic Regulation (IVDR).
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Director, Minnesota OperationsRegulatory And Quality Solutions Llc (R&Q) Oct 2016 - Apr 2017Monroeville, Pa, UsLeader for consulting operations for region covering Minnesota, Wisconsin and Illinois. Large independent consulting firm that focuses on helping companies with the complex quality and regulatory requirements in the medical device industry.Focused on ensuring client companies are ready for ISO 13485:2016, Medical Device Single Audit Program (MDSAP) and the updates to world-wide regulations.
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Senior Consultant/TrainerOriel Stat A Matrix Jan 2018 - Apr 2019Washington, Dc, UsOriel STAT A MATRIX helps organizations reduce costs and risk by achieving compliance with global regulations and improving business processes. The company’s consultants and trainers provide a full range of Regulatory Affairs, Quality Systems & Quality Assurance, Lean Six Sigma, and Performance Improvement training, coaching, and consulting support for medical device organizations and other industries around the world. -
Senior ConsultantOxford International Feb 2015 - Dec 2016Beverly, Massachusetts, UsPerform internal and supplier audits. Gap analysis to requirements of medical device regulations as well as ISO 13485:2016. -
Director, Medical Technology Quality Graduate ProgramSt. Cloud State University May 2014 - Dec 2016St. Cloud, Mn, UsLeader of this Graduate Level program offering both Graduate Certificates and Master of Science degrees in Medical Technology Quality with classes in Plymouth, MN and online. If you are looking to advance your career in medical device quality or get into the medical device industry, this program is for you. -
Director Quality AssuranceOrgan Transport Systems, Inc. Jan 2013 - Dec 2016Establishment of Quality Management System compliant with 21CFR820 and ISO 13485 for design and development of class 2 medical devices.
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Instructor/ConsultantOriel Stat A Matrix Mar 2016 - Oct 2016Washington, Dc, UsInstructor for several courses for quality management systems including US QSR, ISO 13485:2016, auditing and calibration.Provided consulting services for various clients on quality management systems for compliance to ISO 13485 and ISO 9001.
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Principal Quality EngineerSt. Jude Medical Jun 2012 - Nov 2012St. Paul, Minnesota, UsManager for 3 quality engineers responsible for the operational quality of Tissue Heart Valve production. Interface with managers for tissue valve value stream. -
Principal Product Assurance EngineerMedtronic (Cardiovascular Business) May 2008 - Jun 2012Recruited by previous Medtronic manager as project leader for several continuous improvement projects. Quality group team leader for acquisition integration for post market product quality group. Provided cross-functional support for integration of regulatory and clinical systems.• Led project to restore compliance to international standard and regulations for risk management files. Newly created process was recognized by notified body as a ‘best practice’ during follow up audit.• Collaborated with peers in company group-wide product risk management council, including lead role in development of post market surveillance processes, ensuring company leadership. Drove product performance improvements through corrective and preventive action (CAPA) system and continued enhancement of core quality systems.• Supported regulatory submissions and responded to inquiries by notified bodies and other regulatory agencies.• Recognized as key individual contributor to systems and operational post-acquisition integration of 2 different small medical device company acquisitions. Led Risk Management and Post Market Quality team that advanced Medtronic mission and continued to drive performance excellence.• Managed effort to determine required verification activities (IQ, OQ, PQ) for post-acquisition facility move / consolidation, including effect on product design dossier and required regulatory submissions.• Led effort to align business unit Clinical Evidence Report (ISO 14155) and Post Market Safety Report processes, driving compliance with European Medical Device Directive.• Led update of business unit investigation processes (Situation Analysis/Health Hazard Analysis and Field Corrective Action) to accelerate solutions to mission critical issues by interfacing with operations, regulatory, customer service, sales and other engineering groups, setting the bar for critical issue investigation processes throughout the corporation.
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Financial AdvisorFirst Command Financial Planning Apr 2006 - Jun 2008Fort Worth, Texas, UsComprehensive personal financial plans created and implemented for individuals and families.Qualified Financial Advisor with series 6, 63 & 65 securities licenses and all lines of insurance. -
Principal Quality Assurance EngineerMedtronic Aug 2000 - Aug 2006Minneapolis, Mn, UsPrincipal Quality Engineer 2003-2006Led electronics manufacturing quality group of 3 engineers and 3 technicians. Provided leadership for 40 person quality assurance group.• Created model visual management presentation showing complaint information and continuous improvement efforts.• Completed highly visible development project, launching new product line with no major quality issues.• Managed calibration lab following audit creating remedial action plan, resulting in area noted as high performing. Design Assurance Engineer 2000-2003Combined Design Control Methodology of 3 separate entities to form the business unit. First electrical engineer in over 10 years.• Combined different processes into 1 single quality system in the areas of Design Control, Verification and Validation, Risk Management and complaint handling, integrating into single compliant quality management system that allowed combination of different notified body audits.• Assigned Design Assurance responsibilities for all electronic products in business unit. Developed a best practice for visual management of issues and metrics for customer focused quality. -
Field Service EngineerUniversal Instruments Oct 1997 - Aug 2000Conklin, Ny, UsResponsible for the installation and service of machinery for the automated placement of surface mount components on a manufacturing floor, including programming of PLC board handling equipment. Provide initial and advanced training for machine operators and maintenance personnel on operator interface software.Interface directly with Manufacturing and Process Engineers for production operation and throughput optimization for components ranging from 0402 to 2" square with extensive involvement with placement of flip-chips and other C4 components on both flex circuits and printed circuit boards. -
Navigator/Administrative OfficerUss Princeton (Cg Mar 1996 - May 1997Directly supervised all ship's movements, responsible for all bridge watchstanders and accountable for all ship's office functions for 400-person crew.Effectively planned and executed navigation plan for 6-month Eastern Pacific and Caribbean deployment and entire 8-month pre-deployment cycle.Implemented ship's Total Quality Leadership program. Served as command Total Quality Leadership Coordinator, responsible for providing Total Quality training to entire 400-person crew and personally training all upper and middle management personnel.Executed complete revision of Ship's Organizational and Regulations Manual, a backbone document for routine shipboard operations.
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Surface Warfare OfficerUs Navy Mar 1992 - May 1997Washington, Dc, UsUS Navy Officer of the Line (command responsibilities). -
Weapons Department OfficerUss New Orleans Jan 1995 - Mar 1996Supervised 60 men in three divisions responsible for the accountability of the ammunition for embarked Marine units and the maintenance and operation of all ship's weapons systems.Effectively planned, organized and executed ordnance onload of more than 450 tons of ammunition, worth over $50 million, maintaining 100 percent accountability.Efficiently managed Department budget of over $500 thousand.Received Navy Achievement Medal for outstanding performance during entire tour of duty.
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Electrical OfficerUss New Orleans Apr 1994 - Jan 1995Supervised 30 men in the operation and maintenance of the ship's electrical plant and responsible for the safe use of all electrical equipment by 800 person crew and over 1100 embarked personnel.Qualified as Surface Warfare Officer, first officer onboard ever to complete all required Division Officer qualifications while still filling an engineering department billet.Expertly guided division through arduous Operational Propulsion Plant Examination. The entire electrical plant was noted with only one discrepancy and zero safety discrepancies.Effectively managed department budget of over $500 thousand during shipyard maintenance period.Created new engineering department training program to meet updated requirements.
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Machinery Division OfficerUss New Orleans Feb 1993 - Apr 1994Supervised 35 men in the operation and maintenance of main engineering machinery plant.Expertly supervised pre-deployment maintenance of 26-year-old steam plant. Deploying with zero equipment casualties.Superbly assisted in managing Engineering Department budget of over $300,000 during West Pacific deployment.
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Staff InstructorNaval Nuclear Power School May 1987 - Aug 19871987Completed training and qualified as a mechanical operator in the Naval Nuclear Power program. Included training as a machinist mate operating mechanical equipment (Steam Turbines, pumps and other machinery in engineering spaces
Mark Swanson Skills
Six Sigma
Risk Management
Medical Devices
Lean Manufacturing
Iso 13485
Process Improvement
Cross Functional Team Leadership
Program Management
Project Management
Change Management
Team Leadership
Team Building
Strategic Planning
Software Documentation
Leadership
Business Analysis
Project Planning
Quality Assurance
Microsoft Excel
Analysis
Certified Manager Of Quality
Cqe
Asq Senior Member
Asq
Design Control
Fda
Capa
Manufacturing
Management
Product Development
Training
Validation
Process Engineering
Iso
Continuous Improvement
Fmea
Heart Valves
Iso 14971
Quality Control
Quality Auditing
V&v
Iso 9000
Quality System
Quality Management
Spc
Iso Standards
Verification And Validation
Business Process Improvement
U.s. Food And Drug Administration
Corrective And Preventive Action
Mark Swanson Education Details
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University Of MinnesotaElectrical Engineering -
Argosy University Twin CitiesManagement
Frequently Asked Questions about Mark Swanson
What company does Mark Swanson work for?
Mark Swanson works for Qrx Partners
What is Mark Swanson's role at the current company?
Mark Swanson's current role is Partner at QRx Partners.
What is Mark Swanson's email address?
Mark Swanson's email address is sw****@****oom.net
What schools did Mark Swanson attend?
Mark Swanson attended University Of Minnesota, Argosy University Twin Cities.
What skills is Mark Swanson known for?
Mark Swanson has skills like Six Sigma, Risk Management, Medical Devices, Lean Manufacturing, Iso 13485, Process Improvement, Cross Functional Team Leadership, Program Management, Project Management, Change Management, Team Leadership, Team Building.
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