Quality assurance compliance services provided include:
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Training on existing programs with an emphasis on QSR compliance
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Developing SOPs
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Auditing to ensure compliance with existing SOPs
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Supplier Audits to determine supplier compliance
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Gap Analysis to gauge compliance with QSRs
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Design Control analysis to ensure compliance with QSR design requirements
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Complaint Investigations
Experience
Consultant April 2003 to Present
Services provided include: auditing of and developing/modifying Quality system programs (e.g., CAPA, NCR, complaint investigations, design control, packaging), conducting complaint investigations, auditing responses to 483 issues, providing engineering services in product design development (including package design), and training client personnel on appropriate interactions during an FDA inspection. Clients include medical device manufacturers (implantable devices and test/surgical equipment), IVD manufacturers and research laboratories.
Manufacturing Engineering Manager
Bard Peripheral Vascular (formerly IMPRA) Jan 2000 to April 2003
Managed engineering staff of 8 responsible for supporting production of vascular grafts by improving yields by 10%, reducing costs by $450k/yr and performing line extensions (8mm Distaflo Bypass Graft). Managed $700k budget and provided monthly 90-day projections of expenditures. Maintained R&D project portfolio and presented reviews to corporate. Updated validation specification to industry standards (IQ/OQ/PQ). Reviewed validation protocols and reports. Lead engineer in on-site FDA audits. Reviewed change requests to ensure compliance.
Packaging Engineering Supervisor
IMPRA, A Subsidiary of C. R. Bard, Inc. Jan 1994 to Dec 1999
Designed distinctive packaging incorporating color and icons to distinguish product families. Responsible for redesigning package and labeling for CE compliance for cardiovascular medical devices manufactured off-shore. Responsible for implementing serialization and bar coding of all PTFE products to improve inventory accuracy. Validated packaging and labeling software. Wrote packaging specifications, conducted package integrity tests. Supported ETO sterilization validations. Lead project team to commercialize carbon-lined PTFE vascular grafts. Managed staff and budget for Packaging Engineering department. Lead supplier audits of raw material and packaging supplier.
Staff Engineer
IMPRA, A Subsidiary of C. R. Bard, Inc. Sep 1991 to Dec 1993
Designed and validated packaging and labeling for PTFE cardiovascular patches. Wrote packaging and labeling specifications and conducted packaging testing. Initiated label control database.
OEM Process Engineer
IMPRA, A Subsidiary of C. R. Bard, Inc. Sep 1990 to Aug 1991
Responsible for process development of PTFE OEM products including manufacturing procedures and specifications. Responded to 483 action items.
Mechanical Engineer (5/85-12/87) and Technical Writer (10/88-10/89)
Raycon May 1985 to Oct 1989
Responsible for designing the electronic packaging for Nd YAG laser including design of water-cooled cold plates and specification of mechanical components. Supervised production of 5 printed circuit boards, specified connectors and heat sinks, inspected artwork. Created technical manuals for EDM and laser equipment using photography, graphic arts and technical writing skills.
Education
1989Master of Science in Biomedical Engineering,University of Michigan, GPA 7.5/8.0
1987Post-baccalaureate classes in life sciences,University of Michigan and Eastern Michigan University, GPA 3.9/4.0
1984Bachelors of Science in Mechanical Engineering,University of Washington, GPA 3.4/4.0
Professional Skills
Knowledge of FDA QSR regulations, CE requirements, ASTM/AAMI/ISO test methods (including packaging tests), HIBCC barcode, Windows 2000/Millennium, Microsoft Word, Excel, PowerPoint, Access, Project, EasyLabel (bar code software)
Achievements
Inventor “Dual Supported Intraluminal Graft,” U.S. Patent 5,667,523
Jim Wish’s “Time as a Competitive Weapon,” (lean manufacturing seminar)
Statistics seminars: Review and R&R
Behavioral Interviewing Skills Seminar
RAPS Member
Medical Device Packaging, Courses I –4
Employee of the Quarter, 1997
Facilitator and Team Training
AORN, MDM, HIBCC Conferences
European Medical Device Conference
Anne Bynon
