Mark Bain, Mba, Cqa Email and Phone Number
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Accomplished leader with over thirty years of experience in ISO and FDA regulated operations. For the past eleven years, I have consulted with Johnson and Johnson, Smith and Nephew, Terumo CVS, Sorin Group, and Philips. Roles included either managing or supporting multiple projects including CAPA, supplier quality, product service, post-market surveillance, design controls, Q&R, and QMS remediation. As a BSI certified lead auditor, I’m very familiar with quality systems and their inherent issues. Prior to consulting roles, I managed operations for Alere, ConMed-Linvatec, Gish Biomedical, and 3M.Education:• Masters of Business Administration (MBA)• Bachelors of Science in Business, Business Management and Strategic Planning• ASQ CQA - Quality Auditor• BSI Certified Lead Auditor: ISO13485:2016Career:• Remediated quality systems under FDA citations, warning letters & consent decrees• Implemented quality systems; achieved ISO certification & FDA• Completion of multiple supplier and acquisition audits• Manufacturing Operations and Process Controls• Remote Patient Monitoring• Led multiple businesses to success: domestic and international Specialties:• Quality System Implementation, Integration & Remediation• FDA Citation, Warning Letter and Consent Decree Response• Supplier Qualification and Performance Monitoring• Quality Engineering & Project Management• Quality System Audits & Gap Assessment• Post-Market Surveillance• Corrective & Preventive Action (CAPA)• Advanced Root Cause Analysis• Design Controls, including Manufacturing / Design Transfer• Audit Management and Audit Response• Process Validation, Sampling Plans & Change ManagementMedical Devices• Dental Restoratives and Implants • Cardiovascular Surgical Pumps and Monitors• Oxygenators, Blood Reservoirs, and Tubing Kits• Orthopedic Knee, Hip & Extremity Implants• Automated External Defibrillators
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PresidentQms Professionals Inc Aug 2018 - PresentQMS Professionals (QMS Pros) is a consulting firm that delivers issue specific services and solutions to Medical Device, Pharmaceutical and Biotechnology companies. We accomplish this by working with your team to understand the issues and then reaching consensus on the scope. This ensures that all of the client's expectations are met and their improvement objectives are realized
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Capa FacilitatorPhilips Mar 2021 - Jun 2024Amsterdam, Noord-Holland, NlAssigned as Facilitator to coach owners through CAPA initiation process through closure. Primarily supported CAPAs with significant product or user safety risk and major regulatory audit nonconformances. Supported audit activities and audit responses. -
Philips Healthcare - Capa Project LeadEg Life Sciences Feb 2017 - Dec 2020Reading, Massachusetts, UsProject manager responsible for the remediation of closed and open CAPAs by leading cross-functional CAPA teams through the application of advanced root cause analysis, technical discussions, and the creation of strong effectiveness checks through application of statistical techniques. Supported FDA consent decree remediation activities in variety of roles: CAPA coach, Interim Head of Quality and Regulatory, audit participation, and audit responses. Efforts resulted in the lifting of the FDA consent decree injunction. -
Biosense Webster - Project ManagerOxford Global Resources Sep 2016 - Dec 2016Beverly, Massachusetts, UsAssessed gaps in supplier quality documentation and made changes to align with J&J QMS requirements. Worked with managers and supplier quality engineers to understand regulatory gaps and expected outcomes. Implemented Biosense Webster supplier training strategy so their suppliers could assess component/device risks and create corresponding controls. -
Plexus - Manufacturing EngineerPlexus Corp. Dec 2015 - Jul 2016Neenah, Wi, UsResponsible for the support of PCBAs manufacturing and final assembly operations for four customers. Activities included process validations, process instruction updates, document control updates, quality issue resolutions, RMA instructions, and customer interface for engineering -
Terumo Medical - Project Specialist IiiOxford Global Resources Jun 2014 - Nov 2015Beverly, Massachusetts, UsEvaluated CAPAs for adequacy and updated as necessary to improve their clarity and to ensure there was adequate evidence to support closure. Led CAPA project teams during the investigations, root cause determination, task corrections, and completion of effectiveness checks. Activity included presentations to senior management. Efforts resulted in the lifting of FDA consent decree injunction.
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Smith And Nephew - Senior Compliance And Quality ConsultantEg Life Sciences Oct 2013 - Jun 2014Reading, Massachusetts, UsKey role was assessing and remediating quality and regulatory system with focus on design controls, packaging operations, technical files, change control, facilities, and CAPA processes. Led quality systems remediation with responsibility for 15 project groups.
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Terumo Medical - Project Specialist IiiOxford Global Resources Jan 2011 - Oct 2013Beverly, Massachusetts, UsService remediation project lead for FDA consent decree findings at Terumo Cardiovascular Systems (heart-lung machines and blood parameter monitoring). Primary responsibility was identification and resolution of FDA and ISO regulatory deficiencies. Project manager responsible for process mapping, component traceability, process verification and validation activities, identification of equipment life expectancy, system upgrades, process deficiencies, employee training, and CAPA closure documentation.
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Director Of OperationsGish Biomedical Apr 2010 - Dec 2010UsGISH Biomedical designed, manufactured, and marketed disposable medical devices for various surgical specialties including cardiovascular surgery, orthopedics, and oncology. All GISH products were single use disposable products or had a disposable component. The company’s principal products included oxygenators and oxygenator systems, blood reservoirs, cardioplegia delivery systems, custom cardiovascular tubing systems, central venous access catheters and ports, and blood recovery devices for post-operative use in orthopedic surgeries.Responsible for all medical device operations. Duties included the following:- Management Representative- Facilities- Planning and purchasing- Inventory Control- P and L- Capital expenditures- Quality assurance- Regulatory compliance- Logistics- Customer satisfaction- Maintenance -
Director Of BiometricsAlere, Inc. Apr 2003 - Mar 2010North Chicago, Illinois, UsResponsible for the manufacturing and distribution of medical devices used for the remote monitoring of patients in their homes. Diseases monitored included congestive heart failure, diabetes, coronary artery disease, and chronic obstructive coronary disease. Role responsibilities included engineering, manufacturing, outsourcing, product development, distribution, technical device operations, supplier audits, strategic device partnering, and FDA and ISO compliance. Results- Decreased expenditures by $3M the first year of employment through process improvements- Improved costs by $650K per year through packaging cost reductions and product logistics- Increased revenue by $6M through innovative product introductions and partnership strategies- Implemented 5S, cross functional training, and Poka-Yoke strategy- Reduced product failures by 20% -
Site ManagerConmed Linvatec Aug 1999 - Aug 2002Largo (Tampa Bay), Fl, Us$500M medical device manufacturer/service provider of arthroscopy and power surgical instruments. Led manufacturing operations, maintenance, HR, engineering, safety, environmental compliance, inside sales, IT, product service/assembly, scheduling/forecasting, R&D, capital equipment expenditures, and dotted line responsibilities for quality and regulatory. Held P&L accountability for $125M business through nine direct staff and 10 associates. -
Product Supervisor3M Company Jan 1996 - Aug 1999St Paul, Mn, UsHeld P&L responsibility for $150M division. Led manufacturing operations for pneumatic/electronic surgical equipment and domestic and international service groups. Improved manufacturing process documentation, employee utilization, and vendor relationships.
Mark Bain, Mba, Cqa Skills
Mark Bain, Mba, Cqa Education Details
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University Of California, Irvine - The Paul Merage School Of BusinessInternational Business -
California State University, Long BeachOperations Management And Business Strategy
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California State University, Long BeachOperations And Business Strategy
Frequently Asked Questions about Mark Bain, Mba, Cqa
What company does Mark Bain, Mba, Cqa work for?
Mark Bain, Mba, Cqa works for Qms Professionals Inc
What is Mark Bain, Mba, Cqa's role at the current company?
Mark Bain, Mba, Cqa's current role is President at QMS Professionals Inc.
What is Mark Bain, Mba, Cqa's email address?
Mark Bain, Mba, Cqa's email address is ma****@****orp.com
What is Mark Bain, Mba, Cqa's direct phone number?
Mark Bain, Mba, Cqa's direct phone number is +171474*****
What schools did Mark Bain, Mba, Cqa attend?
Mark Bain, Mba, Cqa attended University Of California, Irvine - The Paul Merage School Of Business, California State University, Long Beach, California State University, Long Beach.
What skills is Mark Bain, Mba, Cqa known for?
Mark Bain, Mba, Cqa has skills like Medical Devices, Process Improvement, Six Sigma, Fda, Cross Functional Team Leadership, Quality Assurance, Iso 13485, Lean Manufacturing, Capa, Quality System, Project Management, Product Development.
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