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@oxfordcorp.com
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Mark Bain, Mba, Cqa is listed as President at QMS Professionals Inc at QMS Professionals Inc, based in Buena Park, California, United States. AeroLeads shows a work email signal at oxfordcorp.com, phone signal with area code 714, 775, and a matched LinkedIn profile for Mark Bain, Mba, Cqa.
Mark Bain, Mba, Cqa previously worked as President at Qms Professionals Inc and CAPA Facilitator at Philips. Mark Bain, Mba, Cqa holds Mba, International Business from University Of California, Irvine - The Paul Merage School Of Business.
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AeroLeads found 1 current-domain work email signal for Mark Bain, Mba, Cqa. Compare company email patterns before reaching out.
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
Listed skills include Medical Devices, Process Improvement, Six Sigma, Fda, and 27 others.
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QMS 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.
Amsterdam, Noord-Holland, NL
Assigned 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.
Reading, Massachusetts, US
Project 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.
Beverly, Massachusetts, US
Assessed 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.
Neenah, WI, US
Responsible 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
Beverly, Massachusetts, US
Evaluated 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.
Reading, Massachusetts, US
Key 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.
Beverly, Massachusetts, US
Service 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.
US
GISH 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.
North Chicago, Illinois, US
Responsible 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.
Largo (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..
St Paul, MN, US
Held 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.
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Mark Bain, Mba, Cqa works for QMS Professionals Inc.
Mark Bain, Mba, Cqa is listed as President at QMS Professionals Inc at QMS Professionals Inc.
AeroLeads has found 1 work email signal at @oxfordcorp.com for Mark Bain, Mba, Cqa at QMS Professionals Inc.
AeroLeads has found 2 phone signal(s) with area code 714, 775 for Mark Bain, Mba, Cqa at QMS Professionals Inc.
Mark Bain, Mba, Cqa is based in Buena Park, California, United States while working with QMS Professionals Inc.
Mark Bain, Mba, Cqa has worked for Qms Professionals Inc, Philips, Eg Life Sciences, Oxford Global Resources, and Plexus Corp..
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Mark Bain, Mba, Cqa holds Mba, International Business from University Of California, Irvine - The Paul Merage School Of Business.
Mark Bain, Mba, Cqa is listed with skills including Medical Devices, Process Improvement, Six Sigma, Fda, Cross Functional Team Leadership, Quality Assurance, Iso 13485, and Lean Manufacturing.
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