20 years experience with the US Food and Drug Administration as a Medical Device Specialist in the Minneapolis District with extensive domestic and foreign experience in medical device facility inspections, investigations, PMA and Post Market PMA audits. Currently providing consulting services and performing Quality Systems "mock FDA audits" and hygiene assessments including all methods of device sterilization and clean room facilities. Numerous years of experience performing high priority, directed assignments involving the full range of medical devices at various stages of product life cycle. Extensive cross-cultural experience in the conduct of international medical device facility inspections. Currently seeking part time and or temporary full time assignment (s) as a Quality and Regulatory Affairs / Quality Systems Specialist in the Medical Device industry, domestic or foreign. Available as a direct hire and or contractor through my personal business, Compliance Plus, LLC.

Highlights:

• Medical Devices
• Management
• Public Health
• Regulatory Affairs
• Audit
• Chemistry
• Facilitator
• Food Processing Industry
• Licensing
• Manufacturing
• Medical Device Quality Systems Expert