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Brian Adkins

Brian Adkins

Quality / Regulatory Affairs Manager

Mar Cor Purification

Quality / Regulatory Affairs Manager at Mar Cor Purification Biolab





Mar Cor Purification

Quality / Regulatory Affairs Manager

Designer/Manufacturer of RO Water Treatment and Purification Systems: (Medical and Commercial). Reporting to Sr. V.P. of Regulatory Affairs in US and Site Operations Manager.

Responsible for overall implementation and site harmonization of our Canadian operations (Burlington, Oakville, and Montreal) Quality Management System (QMS) to be in compliance with applicable U.S. and Canadian Regulatory standards including ISO9001:2008, ISO13485, Health Canada CMDCAS and FDA.
• Organize and schedule quarterly Quality Management Reviews and serve as lead for Internal System and 3rd Party Audits for multiple facilities in Canada.
• Administer and maintain CAPA system and act as Canada CAPA coordinator.
• Responsible for launch, validation and maintenance of QCBD Integrated Quality Management Software within the Burlington manufacturing facility.
• Direct Product Submissions for US FDA 510k and Health Canada Device Licensing.
• Creation of Validation Plans and FMEA’s for RO & DI Water Purification Systems
• Review /Approval of all Validation Protocols ensuring compliance to Design/Contract requirements.
• Executor of MCP Burlington Risk Management and Continuous Improvement Program, ensuring compliance to 14971.
• Responsibility for post-market surveillance and reporting of adverse events to management and appropriate regulatory agencies.

Career medium 06
Career medium 04

Sigma International General Medical Apparatus, LLC.

Sr. Quality Engineer

• Creation of Master Validation Plans (MVP) and associated Validation SOP’s for Software and Mechanical Devices (including fixtures and specialty test equipment).
• Implementation of Design Control Practices that comply with cGMP / FDA guidelines and Health Canada Regulations.
• Lead and conduct IQ/OQ/PQ for all production processes.
• Provide direction of all production Test Method Validation activities.
• Establish Risk Based Assessment systems for Design and Validation of products and systems.
• Creation of Standard Operating Procedures and Practices dealing with Supplier Quality, Risk Management, Validation, CAPA, and Problem Reporting.
• Integration of Supplier Quality Improvement for Device High Risk Fabricated Components


Maetrics, LLC

Project Consultant

Project Team Lead for a design team of 5 people for the development and introduction of new “multiple’ injection molded components. These components were developed to be used as part of a drug delivery system for Parkinson’s patients with global distribution impact. This team ran in parallel path of another project (which I also was lead) that was simultaneously re-designing an existing plastic gastrostomy tube for patient feeding. Responsibilities include:
• Leading design team personnel in creating a product that would meet specific marketing / product specifications and customer expectations. Expected time to Market of this project was approximately 8 months.
• Creation of design and development proposal, verification plan and technical reports.
• Responsible for directing all Injection Mold quotes with domestic and off-shore tooling suppliers along with project coordination with in-house tooling engineers for mold design feasibility.
• Coordination with in house manufacturing engineer of part designs for mold flow analysis, FEA and tolerance analysis utilizing Solid-works 3-D modeling and Mold Flow Analysis software.
• Writing and Submission of project Capitol Expenditure Requests.
• Creation and writing of Technical Notes/Reports, DOE’s and ranging studies, IQ/OQ/PQ protocols, TMV plans, FMEA’s, and GOI work instruction documents.

Career medium 06
Career medium 01

Maetrics, LLC

Validation Consultant

Team Member of Packaging and Components Teams @ Boston Scientific whereby conducting product and equipment remediation validation. Project Focus – Packaging Team: Vacuum-Bar and Tray Sealers, Components Team: Injection Molded Parts and Processes.
• Creation and execution of IQ, OQ, PQ and Test protocols (including Reports) per client SOP.
• Conduct ranging studies and DOE to determine optimum equipment operating ranges.
• Review and creation of various Graphical Operator Instructions per client SOP.
• Utilize MINITAB™ Statistical Software for data analysis and normality testing.
• Design, construct and conduct Test Method Validation for fixtures/measuring devices.


Blue Ridge Metals Corp.

Sr. Quality Engineer

• Supervise Quality personnel in daily activities (Receiving, Final and In-process inspection).
• Directed APQP/PPAP submittals and follow-up for International and Domestic products.
• Corrective Action Champion following 5Y/5P and 8D reporting procedures.
• Conduct monthly Internal Systems Audits as a Lead Auditor.
• Actively served as a team member of Company Wide 5s and TPS enhancement.
• Established Receiving Inspection performance tracking for Preferred Supplier Evaluation.
• SPC planning, analysis and employee training for company wide Quality Programs.
• Performance of Material Testing including: Hardness, Tensile, Spark, and Microscopy.

Career medium 06
Career medium 04

Kendro Lab. Products - Division of SPX Corp.

Reliability & Validation Test Engineer

• Directed powder paint line process improvement team for an overall first pass yield improvement of 37 % with annualized savings of more than $280,000.
• Established validation services as a separate cost and revenue center showing increased sales within the third year of operation of approximately $250,000.
• Conducted software/hardware validation for all products resulting in decreased coding errors, improved reliability and quality along with decreased warranty/service claims.
• Creation of system procedures, work instructions and IQ/OQ/PQ protocols leading to improved internal/external communications on factory approved specifications and validation methods.
• As SQE, responsible for supplier partnership development along with the Purchasing Group in reducing ‘Key’ supplier levels during 3 yr. period.
• As Reliability Engineer, worked closely with technical service and engineering departments in enhancing field service communications. Resulting in 100% retrieval of field failures (over previous level of 75% maximum); providing major unit improvement savings approaching $1.2 million in field service cost, warranty claims, and legal litigation expenses.
• Demonstrated leadership skills as lead auditor of internal systems audits to ensure ISO9001 compliance.


Purchased Parts Group

Sr. Supplier Quality Engineer

• Created a database tracking system for managing all suppliers by commodity group, shipment delivery, quality, labor hours, production line errors and corrective actions.
• Established dock to stock program for all key suppliers, rating performance and tracking supplier contribution to the total cost of quality.
• Responsible for internal calibration and maintenance program.
• Customer liaison for all communications regarding part quality and delivery.
• Conducted First Piece Inspection, Material Testing, and 8D Problem Analysis.
• Training of assembly personnel as required in quality, assembly, material handling and basic data entry.

Career medium 04
Career medium 02

Atlas Precision Plastics, Inc

Quality Manager

Custom Injection Molder serving Electronic, Automotive, Medical and Commercial/Industrial Markets throughout the US.
• Support staff: 10 employees (1 technician, 9 inspectors).
• Conducted Employee Safety & Quality Training
• Implemented use of PPT & Avalon Vision Systems for mold protection and part verification.
• Performed First Article Inspection, GR&R Studies, FMEA, and Process Capability Studies.
• Maintained calibration and gage maintenance program assuring equipment integrity.
• Initiated Supplier Certification Program ensuring quality of received goods.
• Performed Mold design reviews to determine overall manufacturability and potential quality concerns.
• Implemented Raw Material Control programs as part of company strategic cost reduction program.
• Served as key contact representative for UL Site Audits and other 3rd party or customer audits.


Advanced Custom Molders

Quality Engineer / Quality Manager

Injection Molding Operation with a variety of Value added secondary operations (assembly, ink and foil transfer, ultrasonic and fusion welding, painting and other decorative operations).
Serving Automotive, Commerical/Industrial, Electronic, Medical, and Military Markets thoughout North America and some locations in Europe, Middle East and Asia.

• Member of Company Executive Leadership Team with a direct support staff including 21 employees (3 Salary, 18 hourly) between two facilities. Second facility in El Paso, TX.
• Created and Managed Company Quality Budget for both molding facilities.
• Conducted Company Wide Employee Quality Training.
• Performed First Article Inspection, GR&R Studies, FMEA's, DOE and Process Capability Studies.
• Established Incoming Materials Testing and Supplier Certification Programs.
• Implemented and conducted Internal System Audits to ISO9001 Standards.

Career medium 02
Career medium 01

Texas Instruments

Quality Engineering Technician/Shift Supervisor

Plastics Molding Division:
• Supervision of 4 hourly shift inspectors.
• Conducted SPC Training for all production operators, technicians, and inspectors.
• Liaison between Design and Manufacturing Engineering for plastics molded products (new and sustaining).
• Performed First Article Inspection, Incoming Material Inspection, Process Capability Studies as well as Component Failure Analysis.
• Assisted in the development of one of the first Vision Oriented CMM’s.
• Conducted weekly department and division quality-progress meetings as well as reviewing the overall quality performance for the division.


US Navy

Anti-Submarine Warfare Operator

*Active Service as Air Crewman aboard S2G - Served with VS-37 - Last squadron to fly "Stoof". Platform retired in 1976 and transitioned to S3-A Viking.
*S3 Training School at VS-41
*Served aboard USS Constellation (CV64) - Westpac 1978/1979.
*Active Service as Air Crewman aboard S3-A till released from Active Service in August 1979.
*Remained in Active Reserves untill February 1987 - (Reserve Squadron VP-93 out of Detroit and VP-94 NAS New Orleans).

Career medium 04

Ohio University

Industrial Engineering Technology

Shawnee State University

A.A.S, Plastics Engineering Technology