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Mark Swanson is listed as Partner at QRx Partners at QRx Partners, based in Becker, Minnesota, United States. AeroLeads shows a work email signal at izoom.net and a matched LinkedIn profile for Mark Swanson.
Mark Swanson previously worked as Founding Partner at Qrx Partners and Chair/Clerk/Director at Becker Board Of Education. Mark Swanson holds B.S, Electrical Engineering from University Of Minnesota.
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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.
Listed skills include Six Sigma, Risk Management, Medical Devices, Lean Manufacturing, and 46 others.
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A career timeline built from the work history available for this profile.
Minneapolis, Minnesota, US
Partnership 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.
Independent 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.
Monroeville, PA, US
Provide consulting services to medical device companies.
Monroeville, PA, US
Gathering 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).
Monroeville, PA, US
Leader 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.
Washington, DC, US
Oriel 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.
Beverly, Massachusetts, US
Perform internal and supplier audits. Gap analysis to requirements of medical device regulations as well as ISO 13485:2016.
St. Cloud, MN, US
Leader 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.
Establishment of Quality Management System compliant with 21CFR820 and ISO 13485 for design and development of class 2 medical devices.
Washington, DC, US
Instructor 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.
St. Paul, Minnesota, US
Manager for 3 quality engineers responsible for the operational quality of Tissue Heart Valve production. Interface with managers for tissue valve value stream.
Fort Worth, Texas, US
Comprehensive 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.
Minneapolis, MN, US
Conklin, NY, US
Responsible 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.
Directly 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.
Washington, DC, US
US Navy Officer of the Line (command responsibilities).
Supervised 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.
Supervised 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.
Supervised 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.
1987Completed 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
Quick answers generated from the profile data available on this page.
Mark Swanson works for QRx Partners.
Mark Swanson is listed as Partner at QRx Partners at QRx Partners.
AeroLeads has found 1 work email signal at @izoom.net for Mark Swanson at QRx Partners.
Mark Swanson is based in Becker, Minnesota, United States while working with QRx Partners.
Mark Swanson has worked for Qrx Partners, Becker Board Of Education, H & M Consulting Group, Regulatory And Quality Solutions Llc (R&Q), and Oriel Stat A Matrix.
You can use AeroLeads to view verified contact signals for Mark Swanson at QRx Partners, including work email, phone, and LinkedIn data when available.
Mark Swanson holds B.S, Electrical Engineering from University Of Minnesota.
Mark Swanson is listed with skills including Six Sigma, Risk Management, Medical Devices, Lean Manufacturing, Iso 13485, Process Improvement, Cross Functional Team Leadership, and Program Management.
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