Bob Sommerdorf Email and Phone Number
Saint Paul, MN, US
Bob Sommerdorf's Location
St Paul, Minnesota, United States, United States
Bob Sommerdorf's Contact Details
Bob Sommerdorf work email
- Valid
Bob Sommerdorf personal email
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Bob Sommerdorf phone numbers
About Bob Sommerdorf
Bob has owned and managed his consulting firm since 2000 and has held management/leadership positions in start-up and larger medical device companies. His experience partnering with clients includes CEO’s and executives at OrthAlign, Blue Belt Technologies, Smith & Nephew, Getinge, Medtronic, 3M Medical, J & J, Orchid Medical, and iotaMotion among others. Bob has a risk-based, seasoned approach to quality system development, commercialization and integration with an excellent track record when leading or participating on an audit team during external audits.Previously a Senior Training Instructor for DEKRA (AQS Management Systems) RAB/Exemplar Global Accredited Auditor courses that provided an in-depth knowledge set of the ISO standards and currently a Certified Lead Auditor for Medical Devices and Quality Management Systems. Quality and Compliance Specialties: QMS implementation, project management for product and plant transfers, supplier and Contract Manufacturing Organizations management both nationally and international, risk management, new product development, auditing both internal and external organizations, CB and regulatory Agency Audits and facility preparedness, compliance systems including post market surveillance, ISO standards and global medical device regulations, training, Management Review and communication, document and record management included manual and eQMS solutions, and remediations.Medical Device Experience: Class I, II and III devices including sterile orthopedic implants and sterile disposables, surgical robotics and surgical accessories, wound care, and sterile packaging. Manufacturing Process Experience: Injection and thermoform molding, electronic assemblies, PCBA fabrication, metal fabrication (heat treat, passivation, welding, sheet metal), Sterilization (EtO and Gamma) and sterile packaging, corrugated and plastic packaging including ship testing, printing, and translation services.
Bob Sommerdorf's Current Company Details
Venturemed Inc.
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Manager, Quality System and Regulatory Compliance
Saint Paul, MN, US
- Website:
- venturemedgroup.com
- Employees:
- 24
Bob Sommerdorf Work Experience Details
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Manager, Quality System And Regulatory ComplianceVenturemed Inc.Saint Paul, Mn, Us
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Quality System Compliance ConsultantIotamotion Sep 2023 - PresentManaged the ISO 13485:2016 Implementation Project Team, prepares and facilitates Quality System Management Review Meetings, Project Manager for the transfer and closure of the Austin, TX facility to the new Vadnais Heights, MN facility, and established the supplier management process. iotaMotion manufactures FDA DeNovo approved Class II Medical Devices. Key accomplishments include: 1) Project Manager for ISO 13485 Certification Project which was successfully achieved in April, 2024 with one minor Nonconformance.2) Supplier Management, developed supplier management procedure, establish supplier approvals including supplier audits to fully vet the Approved Supplier List, facilitates the periodic supplier review meetings and closure of action items, establishes supplier quality agreements, and managing the transfer project of a critical supplier.3) Conducts Quality Management System Internal Audits and ensures continual inspection readiness and compliance with regulatory requirements.4) Project Manager for the successful transfer of the Austin Facility to the new Minnesota Manufacturing Site. Currently managing the transfer of a critical suppliers manufacturing equipment and inventory. 5) Manages Corrective/Preventive Action and Nonconforming Material processes.6) Prepares and facilitates the Quality System Management Review Meeting with the Executive Management Team.7) Identifies continual improvement initiatives and gets management approval.8) Project lead for Inspection System and Specification Improvement. -
Owner/President/Consultant/Auditor/TrainerImplemented Solutions Jan 2000 - PresentWhite Bear Lake, MnProvides customers with consulting, auditing and training for Quality Management Systems. Performs internal/supplier assessments in conformance with ISO 9001, ISO 13485, EUMDR, MHLW 169, TGMDR, and FDA regulations (21CFR Part 11, 50, 211, 801, 803, 806, 807, 812, 814, 820, 822, 830). Assists organizations with remediation efforts focusing on compliance, quality management systems, or manufacturing issues. Develops sales leads, sets annual goals, and maintains budget.Contract support for Quality System Management, Internal Audit, Supplier Management, and Certification Bodies. Helps organization with problem solving, corrective action, and other improvements efforts to ensure the effectiveness and/or efficiency of their management systems.
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Senior Director Of QualityMedtronic Jul 2022 - Sep 2023Maintained all aspects of an independent quality system (AiBiomed - Santa Barbara, CA) to ensure continued compliance to FDA, ISO 13485, and EU MDD requirements during a plant transfer/closure. Responsible for all quality processes including inspection, nonconforming material, document and record control, product release, and was a key member in removing a product hold. Assessed system and associated risks to make improvements while working with management team and personnel from two locations to ensure an effective product and QMS transfer. Worked alongside Regulatory representative to ensure product complied with all regulations for a Class II (DeNovo approved) Device. Contract position with RQM+.Key Results:1) 2023 Internal Audit conducted with 0 nonconformances, previous results were 5-10 issued.2) Assisted with the resolution of a product hold so product could be shipped to the field.3) Cleaned up a quality system, approved product releases, and facilitated semi-annual Quality System Management Reviews.4) Managed Risk Management Process.5) Performed complaint investigations and determined if complaints were required.6) Lead and coordinated with Service team to ensure product updates and repairs were completed.7) Ensured site preparedness for compliance audits. -
Site Compliance LeadGetinge Jan 2022 - Jun 2022Assessed compliance to Corporate, International Standards, and applicable Medical Device Regulations and ensured site was ready for announced and unannounced audits. Assisted with EUMDR implementation. Developed and maintained the annual Internal Audit schedule, manage audit outcomes and coordinate improvement efforts.Contract position with ALKU. -
Site Compliance LeadJohnson & Johnson Apr 2020 - Dec 2021Contract position with ALKU at Torax Medical.1) Conducted all quality management system internal audits within schedule to ISO 13485, FDA - Brazil - Japan - Australia - EU regulations.2) Brought audit metrics into targets and maintained.3) Led team responsible for Certification Body and corporate audit preparation.4) Participated on MDR implementation team.5) Ensured site preparedness for compliance audits. -
Project Manager - Audit Findings MitigationOrchid Orthopedic Solutions Dec 2019 - Apr 20201) Developed spreadsheet to track and report findings closure. Identified many findings that lacked suitable evidence and investigated to determine if the was evidence to support or if a justification could be written to close out finding with no further action.2) Cleaned up all incomplete audit records including reports and nonconformance’s.3) Assigned nonconformance’s to responsible parties, assisted with resolutions, and closed out by performing verifications.4) Presented results to management.Contract position with Oxford -
Senior InstructorAqs Solutions Aug 2006 - Dec 2019Greater Minneapolis-St. Paul AreaInstructor for Exemplar Global Accredited Lead Auditor and Internal Auditor training for ISO 9001, ISO 13485 and TS16949 courses. Successfully trained over 1500 attendants with a 98.5% success rate. -
Manager Of Training And ConsultingAqs Management Systems Jan 2003 - Aug 2006Saint Paul, MnProvided RABQSA Certified Lead and Internal Auditor Training for ISO13485, ISO9001, and TS16949. Provided consulting to organizations from small start-ups with only a few employees to major global organizations with multple sites and a diverse employee base. Performed internal amd external Quality Management Systems and gap assessment audits to international standards. Co-developed training courses and provided customer specific training for auditing, problem solving, and process improvement. Lead customer 8D problem solving and 5S Improvement teams. Completed Certified Lead Auditor training for ISO 14001 Environmental Management and OHSAS 18001 Occupational Health and Safety.
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InstructorAqs Management Systems, Inc. Jan 2002 - Jan 2003Minneapolis, MnFacilitation and Instruction of Exemplar Global certified Lead and Internal Auditor courses based on ISO 9001, ISO 13485 and ISO/TS 16949.
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External Lead Auditor3M Aug 2019 - Nov 2019Evaluated and reported Internal Audit Results, assist with internal audits, and updated External Audit procedure(s). Key accomplished include:1) Analyzed, summarized, and reported audit results to management. 2) Conducted 3 Divisional Internal Audits and reported to management.3) Developed preaudit checklist for use in preparing for External Audits and updated procedure.4) Assisted with site preparedness for compliance audits.Worked in the Healthcare Division under contract with ALKU. -
Quality ManagerSmith & Nephew Jun 2016 - Jul 2017Plymouth, MinnesotaResponsible for maintaining Quality Management System as Management Representative responsible for compliance to ISO 13485, 21 CFR Part 820, and MDD. Managed employees responsible for product inspection, internal/external audits, Nonconforming Material Process, CAPA, and daily quality operations. Supervised 3 employees and responsible for annual budget. -
Supplier Quality ManagerBlue Belt Technologies Sep 2013 - Jun 2016Greater Minneapolis-St. Paul AreaManage and qualify supply chain with the assistance of the other Supplier Assessment Team members including Operation, Engineering and Materials Management. Maintained the Approved Supplier List and facilitated the Quarterly Supplier Review meetings. Monitored and reported supplier performance metrics for Management Review and Quarterly Supplier Assessment Team Meetings. Ensured supplier compliance with Regulatory and Quality systems requirements including MDD, 21 CFR Part 820, and ISO 13485 through audits, monitoring their certifications/registrations, and other means. Implemented and manages supplier corrective action process. Assists Purchasing and Design Transfer with ensuring suppliers understood product requirements. Qualified new suppliers for two major Product launches including a Class II Surgical Robot and Class III Implantable devices. -
Quality ManagerBlue Belt Technologies Apr 2012 - Sep 2013Greater Pittsburgh Area And Minneapolis, MnAssisted with the development of the Quality Management System based on ISO 13485 and 21 CFR Part 820, Quality System representative for the relocation of the manufacturing of the Navio system (Class 2 - Active Medical Device). Participated in Internal, Certification Body and FDA audits. Approved and maintained Quality procedures/processes. Managed Quality Technicians, Quality Inspectors, Work Environment, Calibration systems, Corrective Action and Nonconforming Material processes. Trained employees on FDA, ISO, and other Quality System program initiatives. Implemented Quality Systems updates in support of new medical devices including a Class 2 Unicompartmental Knee Implant (Stride).
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Account Executive Management ServicesTuv Sud Jan 2011 - Feb 2012New Brighton, MnResponsible for identifying, quoting, and negotiation with new clients needing a Certification Body to assess their Management Systems to the following standards: ISO 9001, IATF 16949, AS 9100, ISO 18001, ISO 14001, ISO 22000, FSC 22000, and SQF. My territory covered North Dakota, South Dakota, Minnesota, Wisconsin, Michigan, Illinois, Iowa, Nebraska, Missouri, Kansas, Arkansas, Oklahoma, Louisiana, and Canada. -
Quality/Regulatory ManagerApothecary Products Inc Sep 2006 - Dec 2010Burnsville, Mn And Saint Charles, MiResponsible for the development of a Quality and Regulatory Management System from ground up that complied to ISO 9001/13485, FDA, Health Canada, cGMP, and numerous retailer private label requirements. Quality Management Systems had to support over 5500 products including Baby, Personal Health, Beauty, Medical Device (FDA Class 1 and 2), Lens Cleaning solutions, Pharmacy Supply, and Arts/Crafts. Supervised Regulatory Affairs Specialist, Quality Technicians, and Quality Inspectors. Ensured global suppliers understood and conformed with all Quality/Regulatory/Customer requirements. Managed budget, established annual department goals, wrote employee reviews, and reported strengths, weaknesses, opportunities, and threats to Executive Management. Participated on Risk Assessment, New Product Development, Safety, and product/process improvement teams during a period of rapid company growth (12-18% annual). Hosted FDA during facility audits of two locations and ensure site preparedness for compliance audits. -
Quality System EngineerSpx Corporation 1997 - Feb 2000Owatonna, Mn And Warren, MiLead Auditor responsible for managing and training Internal Quality System Auditors for multiple sites ensuring conformance to QS-9000. Trained internal auditors, new employees, and managers on QS-9000/ISO9001. Scheduled internal audits in 3 facilities and assigned audit teams. Managed document control, corrective and preventive action, customer complaint, and Continual Improvement processes. Lead Material Review Board (MRB), and supervised Quality Inspectors. Presented Quality Management System status updates at Quarterly Management Reviews. -
Quality ManagerStone Container Jan 1991 - Jun 1996Saint Paul, Mn & Rochester, MnDeveloped a quality management system that was certified to ISO 9001 and AIB requirements for a Food Contact Packaging Manufacturer. Managed Pest Control program and HACCP. Maintained document control, corrective/preventive action system, customer complaint process, and was directly responsible for product quality in a 3 shift operation. Facility produced corrugated sheets and finished boxes. Also responsible for the Rochester, MN location and conducting inter-company Quality and Safety Audits of other facilities. -
Aerospace And Ground Warning System OperatorUnited States Air Force Jan 1987 - Dec 1990Bergstrom Air Force Base, Austin, Texas -
Machine OperatorStone Container Jul 1983 - Dec 1986Ran various machinary including extrusion, bag making, slitters, and printing presses.
Bob Sommerdorf Skills
Quality System
Iso
Quality Auditing
Process Improvement
Auditing
Continuous Improvement
Quality Management
Iso 14001
Manufacturing
Iso 13485
Product Development
Quality Assurance
Lean Manufacturing
Capa
Cross Functional Team Leadership
Business Process Improvement
Iso Standards
Fda
Iso 9000
Ts16949
As9100
5s
Root Cause Analysis
Six Sigma
Gmp
Dmaic
Process Engineering
Kaizen
Tqm
Medical Devices
Operations Management
Haccp
Quality Control
Internal Audit
Occupational Health
Fmea
Change Management
Apqp
Spc
Quality Systems
Quality Engineering
Statistics
Organizational Development
Tl9000
Fda Gmp
Bob Sommerdorf Education Details
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Business Management -
White Bear Mariner
Frequently Asked Questions about Bob Sommerdorf
What company does Bob Sommerdorf work for?
Bob Sommerdorf works for Venturemed Inc.
What is Bob Sommerdorf's role at the current company?
Bob Sommerdorf's current role is Manager, Quality System and Regulatory Compliance.
What is Bob Sommerdorf's email address?
Bob Sommerdorf's email address is wa****@****aol.com
What is Bob Sommerdorf's direct phone number?
Bob Sommerdorf's direct phone number is +141268*****
What schools did Bob Sommerdorf attend?
Bob Sommerdorf attended Bethel University, White Bear Mariner.
What skills is Bob Sommerdorf known for?
Bob Sommerdorf has skills like Quality System, Iso, Quality Auditing, Process Improvement, Auditing, Continuous Improvement, Quality Management, Iso 14001, Manufacturing, Iso 13485, Product Development, Quality Assurance.
Who are Bob Sommerdorf's colleagues?
Bob Sommerdorf's colleagues are Jake Cochran, Quin Gresham.
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