About AdvQSS

Professional Experience

 Advanced Quality System Solutions, San Diego , CA and Park City, UT  2007-present
Principal/Quality System Consultant
A full service quality system consulting company with focus on medical device regulations and standards. 

• Provide strategic compliance solutions in developing new or improving existing quality systems
• Develop value-added quality system documentation (quality manual, SOPs, forms)
• Provide assistance to clients in responding to FDA communications/Warning Letters/483s and developing effective corrective action plans
• Conduct quality system training (CAPA, complaints, etc)
• Provide regulatory/QA support to design teams
• Prepare technical documentation to satisfy MDD and IVDD requirements
• Perform quality system audits:  internal, 2nd party, and 3rd party and prepare written reports

Medical Device Consultants, Inc., San Diego, CA  2005-2007
Provider of worldwide quality system, clinical, and regulatory consulting services to medical device companies

Quality Systems Consultant, reported to Director, Quality and Compliance Services

• Assisted manufacturers and suppliers in developing and implementing quality systems compliant with 21 CFR Part 820, EN ISO 13485:2003, Canadian Medical Device Regulation, MDD, and IVDD, AIMD. 
• Audited quality systems to applicable regs and standards and prepared related audit reports
• Developed compliance strategies to improve client’s existing quality system with focus on complaint handling, CAPA, design control, risk management, process validation
• Conducted client-requested quality system training
• Prepared/reviewed FDA 483 and Warning Letter responses, managed the implementation of related corrective actions to ensure timelines were met
• Contributed to the management of client relations, including meetings, proposals, and ongoing project management
• Delivered presentations at public seminars/workshops designed to broaden the medical device industry’s understanding of compliance and quality system issues
• Performed 3rd party quality system audits on behalf of BSI Management Systems

BSI (British Standards Institution), Management Systems   Reston, VA            2000-2005
Leading provider of quality management system registrations and assessment services spanning a wide variety of industries including:  medical device, aerospace, automotive, and telecommunications. 

Western Area Manager, reported to Assistant Regional Vice President.  Promoted to this position in 2003. 

• Managed western team which consists of 15 assessors
• Ensured assessors were booked to capacity on revenue-earning activities
• Interfaced with clients to promptly address inquiries, complaints, and scheduling needs
• Developed presentations for potential clients interested in EN ISO 13485:2003, CE marking, or ISO 9001:2000 registration
• Managed reduced portfolio of medical device clients and delivered approximately 50 assessment days annually

Medical Device Lead Assessor, reported to west coast area manager                2000-2003

• Performed 3rd party quality system/technical audits in accordance with ISO 9001/EN 46001/ISO 13485/MDD/CMDCAS
• Prepared audit reports providing recommendations for the issue, re-issue, or withdrawal of quality system and CE certificates
• Developed effective partnership with client base so that client expectations were met and positive value was  achieved
• Developed and conducted QSR/QSIT internal training course for medical assessors training in 2003

Genzyme Corporation, Genzyme Surgical Products Division    
Tucker, GA     1996-99

• A global, diversified healthcare products company.  GSP division manufactures surgical instruments (manual, endoscopic and minimally invasive applications), equipment, and accessories for cardiovascular, plastic, and general/GYN surgical procedures. 

Director, Regulatory Affairs/Quality Assurance, reported to the Vice President of Product Technology and RA.

• Provided regulatory/quality system direction, strategic planning, and expertise for the division
• Directed and managed the development of a quality system compliant with QSR/ISO 9001/EN 46001/ISO 13485/MDD
• Acted in the lead capacity during FDA and Notified Body inspections and managed these relationships
• Monitored compliance with all regulations pertinent to marketed devices and products under development
• Served as the RA representative on design project teams, provided guidance and feedback to members, developed regulatory strategies for new products and claims to maximize speed to market
• Interfaced with corporate senior regulatory management to formulate global policies 
• Coordinated, reviewed, evaluated, and compiled documents for regulatory submissions
  Led RA/QA activities to increased productivity levels as measured by completion of department/division objectives
• Trained, mentored, and supervised RA/QA staff 
• Developed department budget and monitored expenditures

 Ortho Development Corporation,  Draper, UT 1994-96

• A start-up manufacturer of total joint reconstruction devices and surgical instrumentation.  A subsidiary, Orion Medical, manufactures alternating pressure air mattresses, stereotactic systems and accessories.

Manager, Regulatory Affairs/Quality Assurance, reported to the CEO. 

• Overall management of the regulatory and quality system functions, including the development of procedures and policies to establish compliance and complement business  objectives    
• Performed internal/external audits, established in-house training program for audit team
• Interpreted regulations and guidance documents and briefed executive management
• Authored 510(k) submissions and foreign government applications, acted as regulatory liaison during review
• Analyzed quality data and determined follow up actions 
• Developed regulatory strategies to support product development and regulatory approvals
• Reviewed labeling and advertising 
• Managed QA/QC staff
• Prepared six 510(k)s cleared by ODE
• Obtained MHLW product approval for (5) devices

Kirschner Medical Corporation, (Biomet) Fair Lawn, NJ1993-94

• A manufacturer of total joint reconstruction devices and surgical instrumentation, orthopedic support products, endoscopic video equipment and accessorie s.  Acquired by Biomet, Inc. in November, 1994.

Corporate Regulatory Compliance Specialist, reported to the Director of Regulatory Affairs/QA. 

• Performed supplier/division GMP audits and prepared audit reports for review by executive/senior management
• Monitored internal and external corrective actions for audit-related deficiencies
• Authored corporate regulatory policies and SOPs
• Processed regulatory complaints and MDRs; acted as recall coordinator and liaison with FDA district office
• Represented RA/QA function during FDA inspection; no observations noted;
• Led and managed cross-functional team to establish a formal quality system at endoscopic video equipment division

C.R. Bard Corporation (Baxter), North Reading, MA 1989-93

• A Fortune 500 manufacturer of a software-driven infusion pump used to administer and deliver analgesic drug therapy.  Acquired by Baxter Healthcare Corporation in March, 1993. 

Quality Specialist, reported to the Quality Manager

Education and Professional Affiliations
Bachelor of Arts degree, University of Massachusetts
Regulatory Affairs Certification (RAC) 1999
ASQ Biomedical Auditor Certification (CBA), #226, 2005
Professional Affiliations:  RAPS, ASQ Biomedical division, Orange County Regulatory Affairs (OCRA); San Diego Regulatory Affairs Network (SDRAN)
Contributor to RAPS Focus magazine

Guest speaker on topical subjects:

• SDRAN RAC Study Groups 2000, 2001:  Medical Device Regulations 21 CFR Part 803, 820
• Medical Product Development certificate program, UC-Irvine Extension, January 2002: Quality System Regulations 21 CFR Part 820
• SDRAN Medical Device Conference, Sept. 2003:  Canadian Medical Device Conformity Assessment Systems
• Northern California Discussion Group, ASQ Biomedical Division May 2005:  EN ISO 13485:2003, Process Based Approach
• Institute of Validation Technology Medical Device Workshops, August 2006:  Post Market Surveillance:  Why Complaints Aren’t (Usually) Enough
• MD&M West Conference February 2007:  CAPA—Common Pitfalls and How to Avoid Them
• ASQ, Las Vegas Section February 2007:  An Effective CAPA System for Medical Device Manufacturers
• MD&M West Conference January 2008:  Documentation Management for the Medical Device Industry (co-presenter)
• ASQ, Las Vegas Section Dec. 2009:  Transitioning from ISO 9001:2008 toISO 13485:2003--Going After the Medical Device Business