Mark Spain Email & Phone Number

Raleigh-Durham, North Carolina Area

Publishing articles of general wine interest while also focusing on wines in the Triangle Region of North Carolina at winetimenc.com.

Raleigh-Durham, North Carolina Area

Global quality management responsibility for biotechnology research, including quality system auditing and process risk assessment.

Established and administered the quality management system for a medical device start-up venture developing synthetic hydrogel sealants for general and specialty surgery. Formulated policies and procedures to ensure compliance with all applicable standards and regulations, and to promote effective business operations.

Managed quality function for medical device company commercializing cyanoacrylate adhesives for wound closure. Regulated work of contract manufacturers to ensure fulfillment of quality requirements and collaborated with marketing partners to deliver defect-free products and respond to user inquiries.

Audited quality systems of medical device companies and their suppliers. Developed quality system documentation to improve processes, ensure compliance with regulatory requirements, and achieve registration to international standards. Worked together with other consulting groups on re-engineering and system integration projects.

Managed quality and regulatory functions for manufacturer of in vitro diagnostic devices. Oversaw all quality assurance activities (document control, CAPA, complaints, nonconformances, etc.) and day-to-day operations of the quality control laboratory. Prepared and submitted 510(k) applications for new products and product changes, and worked with FDA on clearance.

Responsible for resolving production and testing problems, establishing and revising raw material and finished goods specifications, evaluating product shelf life, and providing analytical support for special projects.