Senior Quality Consultant
Brian has 29 years of experience in Quality, Regulatory, Compliance, Engineering and Manufacturing in the medical device and pharmaceutical industries. He has extensive experience interfacing with FDA, notified body and other regulatory bodies including 483 and warning letter responses, CAPA leadership, inspection management, recall planning and execution and remediation project management. Brian is an expert in deployment of quality systems and manufacturing processes.
- Directed all aspects of quality and regulatory affairs including: quality engineering, complaint and nonconformance handling; risk management, regulatory product registration and event reporting; quality management system.
- Management representative and principle laison with FDA regarding quality system correction and warning letter remediation, project remediation and field corrections.
- Led the quality planning process, integrating with business strategy and plans, and aligning organizational resources to achieve strategic objectives and monitoring results.
- Identified, developed and delivered education and training programs.
- Directed customer service department including customer call center and complaint receipt, remote customer support and product installation and field service.
- Managed multi-site corporate compliance program for worldwide regulations including FDA QSR, Medical Device Directive.
- Managed corporate risk management program in accordance to ISO14971 encompassing risk prevention, hazard analysis, health hazard evaluation, DFMEA/PFMEA risk assessment, and oversight of product liability cases. Principle investigator for all patient injuries or death.
- As director of quality and regulatory management/corporate compliance manager:
- Managed execution of over 40 product recalls including chair of risk review board (recall decision body), including FDA reporting requirements of 21 CFR 806
- Managed 483 response action plans, including comprehensive systematic upgrade to subsystems
- Upgraded supplier controls system to GHTF/SG3/N17:2008
- Management lead for critical CAPA project (483 responses), led CAPA remediation program
- Remediation of software validation system to satisfy 21 CFR 820.70 (i), 21 CFR 11, TIR36
- Internal SME for the software validation work stream, covering product, process and quality system software
- As QA Manager:
- Design authority and responsible for managing the change management system
- Led initiatives for process improvement and continuous product quality improvement
- Responsible for effectiveness and efficiency of key quality system elements
- Guided supplier selection and performance management processes
- Led risk analysis investigations and product malfunctions
- Led the complaint management processes
- Succesfully completed validation remediation activities for process equipment, utility, and facilities for Eli Lilly and Company.
- Senior Quality Consultant – BioTeknica, Inc.
- Executive Director – Quality, Regulatory and Customer Service – Xoran Technologies, Inc.
- Director of Quality – Xoran Technologies, Inc.
- Director – Quality Management Systems Auditing – Terumo Cardiovascular Systems, Inc.
- Director of Quality and Regulatory Management/Corporate Compliance Manager – Terumo Cardiovascular Systems, Inc.
- Quality Assurance Manager – Terumo Cardiovascular Systems, Inc./ 3M Healthcare
- Manager of Product Development QA – UMM Electronics, Inc.
- Quality Services Manager, PCB & Medical Device Mfg. – UMM Electronics, Inc.
- Senior Quality Services Engineer, PCB & Medical Device Mfg. – UMM Electronics, Inc.
- Team Leader/Facilitator, Pharmaceutical Manufacturing – Eli Lilly and Company
- Production/Facility Engineer, Parenteral Filling Operation – Eli Lilly and Company
- Industrial Engineer/Business Manager – Procter & Gamble Paper Products
- B.S., Mechanical Engineering – Rose-Hulman Institute of Technology
- RAB/QSA Certified Lead Quality Management Systems Auditor, Certificate Number 114187
- ISO 13485:2003
- FDA QSR 21 CFR 820, cGMP
- ISO 14971 – Risk Management
- 21 CFR 803 – Medical Device Reporting
- 21 CFR 11 – Computer Systems and TIR36
- 21 CFR 806 – Corrections and Removals
- Root Cause Analysis
- Medical Device Directive
- Total Quality Management
- Performance Excellence
- Statistical Process Control
- Reliability Management
- AMA New Manager Course
- High Purity Water Systems
- Interaction Management Training
- Business Leadership
- Process Validation
- Project Management
- UL/CE Certification
- Kepner-Tregoe Troubleshooting