Clients include:
• Startups, medium sized and large corporations
• Medical device companies
• Biotech companies
• Pharmaceutical companies

References available on request

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Client projects have included:

Training
• Custom training design and delivery for clients’ systems and needs
• Upgrades to client’s existing training materials
• Working with client’s subject matter experts to develop and/or deliver training
• Delivery of client’s existing training programs
• Coaching for clients’ trainers’ growth and development
• Back filling for trainers on project assignments

Auditing
• QSR and ISO based auditing
• Internal audits for all or selected systems
• Supplier audits: qualification, routine, and for-cause audits

General
• Developing new quality systems
• Transitioning existing quality systems into 21CFR Part 820 compliance
• Process re-engineering
• Compliance project support
• Document writing and review
• Interim manager/staff member

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Speaking Engagements:

• 2005, 2006 Stanford University, Program Guest Lecturer, Biodesign Innovation Program 
• 2009, 2010 Stanford University, Co-lecturer with Jan Peizsch, Ph.D., Biodesign Innovation Program Course syllabus

• Feb. 2009
Medical Design & Manufacturing West, Presenter on Design Controls

• Oct. 2008
Medical Design & Manufacturing Minneapolis, Presenter on Design Controls

• May, 2006
PDA Biennial Training Conference

• 2001-2002
ASQ Biomedical Trainers Conference, Host and Presenter 2001, Co-host and Presenter 2002

• 1998
ISPE (International Society of Pharmaceutical Engineers), Presenter

• 1995, 1997
GMP Training and Education Association (East Coast), Presenter

• 1993, 1994,1995, 1996
GMP West Coast Trainers, Chairperson and Presenter


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Industry positions:

ALIGN TECHNOLOGY, Santa Clara, CA
Director of Quality — 1999 to March 2002
Took product “Invisalign” invisible braces (Class I) pre-IPO through IPO and national/international launch.
Managed development of quality system from basic structure in US, to ISO 9001 certification and FDA QSR compliance for US and Pakistan operations. Worldwide Management Representative responsible for corrective and preventative action, auditing, quality systems training, document control, quality engineering. Received inspection, processed auditing programs, and supported supplier quality, validation/qualification, and design control. Developed Quality Department staff from 1 to 20 employees.
- Achieved initial ISO 9001certification in US and Pakistan on schedule, within nine months of request date, supporting an on-time product launch in Europe.
- Hosted three successful audits with State of California FDA, negotiated continuous manufacture of product during move to new manufacturing site.
- Instrumental in developing systems to support rapid company growth, allowing for expansion of systems during staff growth from 80 to over 1400 employees in 1.5 years.

METRIKA, Sunnyvale, CA
Quality Manager — 1998 to 1999
Handheld in-vitro diagnostic analyzers (Class II), pre-IPO/pre-launch.
Recruited to develop the overall quality system, with direct responsibility for document control, auditing, and QS Training.
- Developed a cross-functional team that implemented an FDA QSRs-compliant system
   in 10 months.
- Passed initial State of California certification audit on time, with no non-conformances.
- Facilitated quality system audit and approval by a potential marketing partner (large-scale pharma/device firm), enabling entry into a key marketing partnership agreement.
- Provided team support to R&D and manufacturing projects as well as overall compliance guidance to the company.

HEARTPORT (now owned by Johnson & Johnson), Redwood City, CA
Senior Quality Specialist — 1996 to 1998
Minimally invasive heart surgery (Class II)
Developed and delivered quality-system training, quality-system auditing program, R&D team support; designed history file audits, supplier-quality audits, ECO review/approval; and provided general compliance support.
- Co-hosted successful FDA audits and ISO 9001 audits.
- Developed modularized training program for the assembly staff and cross-functional audit teams, resulting in increased compliance and understanding of quality-system objectives.
- Contributed to multiple design projects, thorough risk analysis, participation in design-control meetings, and review and release of DHF prior to launch.

BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS (now BD Bio-Sciences), San Jose, CA
Supervisor of Training and Education — 1995 to 1996
Sr. Training and Education Specialist — 1993 to 1995
Flow cytometers and reagents (Class II)
Designed and delivered quality-systems training, conducted quality-systems audits and supplier-assessment audits, co-hosted FDA and TUV electrical safety audits, provided design-control support. Promoted to supervisor of group, adding calibration and device-history files to responsibilities.
- Co-hosted and hosted successful state FDA, ISO 9001 audits, and TUV electrical safety audits.
- Designed innovative and successful training programs, resulting in increased associate understanding and support of quality-system requirements.
- Qualified numerous suppliers and contract suppliers.

SYVA CO. (recently known as Dade Behring), Cupertino, CA
Sr. Quality Specialist, Quality Specialist — 1990 to 1993
Master Scheduler, Production Planner, Ranch Coordinator, Production Tech I, II — 1979 to 1990
In-vitro diagnostic reagents and instruments
Provided quality-system training, quality-system auditing, R&D team support, design-history file audits, supplier-quality audits, and general compliance support. Co-hosted FDA audits, and Drug Enforcement Agency (DEA) audits.
- Leveraged knowledge of company to design GMP training programs and conduct system-level audits.
- Qualified numerous suppliers, facilitated dramatic improvements in contract supplier quality.
- Acknowledged for producing consistently positive results and implementing improvements, resulting in six internal promotions in 14 years.

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Education and Certifications:
ASQ CQA Biomedical (Certified Biomedical Quality Auditor, American Society for Quality)
AA in Quality Assurance, with honors, De Anza College
APICS CPIM (Certified Production and Inventory Management) 1985-2003

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Affiliations:
American Society for Quality, San Francisco Biomedical Division—Member

Personal Note:
Michelle Paganini was known as Michelle Babcock prior to June 2000