Consultant
Professional with solid compliance knowledge, skilled in quality management systems. Highly credentialed with years of experience with medical device and drug manufacturers. Background concentrated in in vitro diagnostics and sterile/reusable surgical medical device products.
CORE COMPETENCIES
- FDA Inspections/Remediation
- Precertification Audits/ISO Audits
- Gap Analyses/ Internal Audits
- External Audits/Supplier Audits
- Product Audits/Process Audits
- Design History File Audits
- Batch History Reviews
- Quality System Development
- Corrective and Preventative Action
- Complaint Investigations/Product Recalls
- Adverse Event/Medical Device Reporting
- Label Review/Approval
- FDA 21 CFR Parts 820/210/ 211
- ISO 9001/ISO 13485
- SOR/98-282
- Auditor Training/Procedural Training
SELECTED ACCOMPLISHMENTS
- Conducted audits of medical device manufacturers for major international accredited third party management system certification registrars for assessment and registration to the criteria set forth in ISO 9001 Standard Series and applicable related sector standards, including ISO 13485
- Completed audits for compliance with 21 CFR Part 820 for medical device manufacturers of reusable and sterile disposable products
- Performed audits for compliance with 21 CFR Parts 210/211 for drug manufacturers
- Managed various project activities for largest medical device manufacturer of minimally invasive surgery products, specializing in urology and gynecology, including:
- Administered, monitored, and audited quality system, reporting status of system and its effectiveness to upper management as related to ISO 9001, ISO 13485, and 21 CFR Part 820
- Upgraded quality manuals to ISO 9001 requirements
- Developed process validation procedures for product sterilization, utilizing gamma, ethylene oxide, and electron beam sterilization
- Coordinated complaint program, specifically activities related to investigations, ensuring that incidents reported accurately, Medical Device Reports (MDR’s) submitted in accordance with 21 CFR Part 803, and complaints closed out in timely manner
- Submitted appropriate technical information for international device registrations
- Participated in Material Review Board (MRB) meetings to determine disposition of nonconforming material based upon investigations to identify root cause and appropriate corrective and preventative actions
- Participated in Engineering Change meetings to assess need for revalidations
- Developed and implemented procedures for improved operations and enhanced compliance
- Conducted training on Quality System Regulation (QSR)
- Facilitated numerous compliance activities for medical device manufacturers of coagulation testing and therapeutic devices, including:
- Conducted reviews of Device History Records (DHR’s) to ensure lots manufactured in accordance with Device Master Records (DMR)
- Developed and implemented documentation, including Standard Operating Procedures (SOP’s) and work instructions, required for addressing gaps in quality systems
- Managed several clinical qualification and regulatory affairs undertakings for medical device manufacturer of in vitro diagnostics used in hematology laboratories, including:
- Organized and led internal audits as required by internal audit program
- Conducted compliance audits of manufacturing areas for various operations
- Coordinated recalls, specifically development of recall strategies, identification of impacted product, and removal and/or correction of product
- Processed customer complaints, handling investigations, identification of root cause, and documentation of records
PROFESSIONAL EXPERIENCE
- Independent Consultant/Auditor for DEKRA Certification, Inc. (Willow Grove, PA) – 1999 to Present
- Independent Consultant/Auditor for Keystone Technical Associates (Willow Grove, PA) – 1999 to 1999
- Circon Cabot, Complaint Coordinator (Langhorne, PA) – 1996 to 1999
- Circon Cabot, GMP Compliance Coordinator (Langhorne, PA) – 1994 to 1996
- Circon Cabot, Quality Assurance Engineer (Langhorne, PA) – 1988 to 1994
- Independent Consultant, Principal Consultant/Contract Auditor (Willow Grove, PA) – 1987 to 1988
- Geometric Data Corporation, Manager, Clinical Qualification/RA (Wayne, PA) – 1981 to 1987
- Geometric Data Corporation, Manager, Clinical Qualification (Wayne, PA) – 1979 to 1981
- Geometric Data Corporation, Chief Technologist (Wayne, PA) – 1978 to 1979
- Geometric Data Corporation, Senior Technologist (Wayne, PA) – 1975 to 1978
- Abington Memorial Hospital, Hematology Technologist (Abington, PA) – 1971 to 1975
- Royal Perth Hospital, Cytogenetics Technologist (Perth, Australia) – 1969 to 1971
- Temple University, Research Technologist (Philadelphia, PA) – 1968 to 1969
- Abington Memorial Hospital, Hematology Technologist (Abington, PA) – 1964 to 1968
EDUCATION
- Bachelor of Science in Medical Technology, Temple University, Philadelphia, PA – 1961 to 1964
CERTIFICATION
- Certified Quality Auditor (CQA), American Society for Quality – 1992 to Present
- Certified Lead Auditor for ISO 13485/ISO 9001 (Certificate #6876), RABQSA – 1998 to Present
- Lead Auditor for Medical Devices Quality Systems for ISO 13485, ISO 9001, and EAC/IEF codes: 12, 14, 19, DEKRA Certification Inc. (formerly KEMA Registered Quality Inc.) – 7/09 to Present
TRAINING
- Auditor Training, KEMA Registered Quality Inc. – Annual training 2001 to 2012
- Canadian Medical Devices Conformity Assessment System, Health Canada – 2001
- ISO/DIS 9000:2000 Overview, American Society of Quality – 2004
- Advanced Auditing of Management Systems, Quality Management International, Inc. – 2008
- Survey of Basic Statistical Methods Useful to MDD & ISO Auditors, KEMA – 2010
- Elementary Statistics (Statistics 101), Penn State – 1985
AFFILIATIONS
- American Society for Quality (ASQ) – 1989 to Present
- American Society of Clinical Pathology (ASCP) – 6/64 to Present
