EXPERIENCE
Consulting Firm 03/10- Present
Industry Consultant
- Leading a consulting firm providing competent direction and guidance to medical device clients in support of their goal to comply in all aspects of domestic and international quality and regulatory regulations including FDA (QSR), Medical Device Directive (93/42/EEC) and Canadian Medical Device Regulations (CMDR) as well as international standards ISO 13485, ISO 14971, IEC 60601.
Significant Projects:
- Multiple 510(k) submissions for domestic and foreign medical device manufacturers
- Multiple remediation projects either as a team member or as a team leader
- Provided regulatory review and guidance of labeling for several medical device manufacturers
- Provided quality system assessments of domestic and international medical device companies and suppliers for compliance to FDA (QSR) requirements
- Presently retained as a regulatory consultant for a Boston-based medical device distributor.
Aurora Imaging, Inc., North Andover, MA 02/08 – 03/10
Director of Quality Assurance & Regulatory Affairs
- Provide strategic leadership and set policies for quality and regulatory standards, assuring that the Quality System is compliant with FDA (QSR) and applicable regulatory standards such as MDD 93/42/EEC, CMDR ,ISO 13485, ISO 14971, and IEC 60601 requirements.
Accomplishments:
- Successfully resubmitted a 510(k) previously rejected by the FDA’s ODE as a special 510(k)
- Attained international registration and licensure for SFDA, (China), Taiwan, Thailand and Brazil
- Provided guidance and direction for successful FDA inspection after FDA warning letter in 1995.
Medpoint Services, NC 11/07 – 02/08
GMP Consultant
- Contract assignment in the areas of medical device manufacture, and quality systems for a Boston-based medical device facility undergoing FDA warning letter reconciliation
Philips Medical Systems, Andover, MA 02/01 – 10/07
Quality & Regulatory Manager, New Ventures Division
- Provided strategic leadership and set policies for quality and regulatory standards, assuring that the Quality System is compliant with FDA (QSR) and applicable regulatory standards such as MDD 93/42/EEC, ISO 13485, FCC, RTTE, and EMC requirements in addition to company and divisional quality system requirements
- Monitored and interpreted new regulations and industry trends, providing strategic direction to Executive Management to proactively ensure that New Ventures products and operations are at the forefront of quality and compliance regulations
- Developed and maintained collaborative relationships with key personnel in external regulatory agencies, fellow quality professional colleagues and internal support resources
- Routinely monitored progress against expectations
- Assured that quality system metrics are defined and monitored and that appropriate action is taken when adverse trends are observed. Provide routine and timely reports to Executive Management
Accomplishments:
- Compliance to CMS BBS (Balanced Business Scorecard) quality system metric levels for nine (9) consecutive quarters
- Submitted and received timely 510(k) submission clearances allowing early product release
- Team member on various CMS-wide systems quality system improvement task forces resulting in reallocations of business and engineering resources.
ETL SEMKO, Boxborough, MA 09/00 – 02/01
Quality Services Manager, Intertek Testing Services
- Responsible for coordination and review of testing client registrations for compliance to Intertek and SEMKO requirements and applicable national and international quality system requirements
- Selected by SEMKO of Sweden to be sole qualified microbiology assessor to ISO and EN standards
Quality Systems Consultant 02/00 – 09/00
- Various and varied contract assignments in the areas of medical device manufacture, quality system and MDD assessments as well as pharmaceutical manufacture for the following companies:
- Micro Med., Inc., Portsmouth, NH
- NutraMax, Gloucester, MA
Becton-Dickinson Ophthalmic Systems, Waltham, MA 1995 – 2000
Manager, Quality Assurance and Regulatory Affairs
- Regulatory activities including 510(k) submissions, foreign country product registrations and product device master records and EU MDD technical file maintenance
- Regulatory compliance including GMP maintenance to FDA (QSR), MDD and EN 46001 requirements, complaint system to domestic FDA (MDR’s) and European vigilance requirements.
Project Manager:
- Managed team responsible for CE Mark implementation for entire Beaver blade product line
Chairman:
- Led P.A.C.E. team for business review of strategic new product development activities
Team Leader:
- Due Diligence team leader for QA/RA acquisition activities of facilities in Florida and United Kingdom
Becton-Dickinson Surgical Systems, Waltham, MA 1993 – 1995
Manager, Quality Assurance
Top Priorities:
- Monitored microbiology of bioburden and environmental testing of controlled rooms to BS 5295 requirements
- Validated sterilization processes (ETO and GAMMA) to BD Corporate, DOH and AAMI standards
Project Manager:
- Responsible for plant-wide implementation of ISO-9000 certification, which resulted in certification by BSI to EN 29001 and EN 46001
Project Leader:
- Initiated and led plant to achieve registration to UK-DOH GMP standards
- Conducted and coordinated internal GMP audits and vendor audits
- Created and implemented Cost of Quality and Outgoing Quality Index reporting which monitored continuous improvements for plant-wide activities
Becton-Dickinson Acute Care, Waltham, MA 1988 – 1993
Manager, Quality Control
- Managed budget of $500,000 and supervised 18 employees
- Directed changes in quality systems resulting in FDA GMP compliance
- Directed quality engineering projects resulting in process validation of critical process including all packaging sealing processes
- Directed the training of quality and manufacturing and engineering in Taguchi design of experiment techniques
- Responsible for minimizing of bioburden for compliance to FDA and DOH microbiology requirements
- Reorganized incoming and final departments to focus on quality requirements
- Established comprehensive three year plan for quality department direction
Leadership:
- Organized a plant-wide implementation strategy for ISO-9000 certification to be completed in 1995
- Member of the BDAC BMT (Business Management Team)
- Conducted GMP training for plant of 160 employees
- Conducted and coordinated internal GMP audits and vendor audits.
GENETICS INSTITUTE, Andover, MA 1988 – 1988
Senior Quality Assurance Specialist
- Set up Quality Assurance unit in support of FDA Good Laboratory Practice regulations (GLP) for a pre-clinical testing department of a large biotechnology firm
- Conducted audits for GMP and GLP compliance for internal and external vendors this included local, national and international locations
- Conducted Good Manufacturing Practice (GMP) Training for process operators and quality control and quality assurance personnel
Medtronic- Andover Medical, Haverhill, MA 1984 – 1988
Manager, Quality Control/Assurance
Haemonetics, Braintree, MA 1982 – 1984
Manager, Quality Control
Custom Contact Lens Lab (Precision- Cosmet), Boston, MA 1977 – 1982
Manager/Principal, Quality Control
Holy Family Hospital, Methuen, MA 1967 – 1977
Clinical Laboratory Supervisor
- Responsible for day-to-day operations involving all facets of the laboratory
EDUCATION
- MS, Medical Lab Science, Northeastern University, Boston, MA
- BS, Microbiology, University of Massachusetts, Amherst, MA
CERTIFICATIONS / TRAINING
- Certified Quality Engineer; CQE (ASQ)
- Certified Quality Manager, CQM (ASQ)
- Certified Microbiologist; M (ASCP) SM/RM (AAM) SM
- Certified Medical Technologist; MT (ASCP)
- Trained as an ISO-9000 lead auditor by the British Standards Institute and Stat-A –Matrix
ASSOCIATIONS
- American Society for Quality (ASQ)
- New England Biomedical Discussion Group (ASQ)
REFERENCES
- Available upon request