Ridge Rim Associates, LLC

Cory J. Smith

Cory has over 20 years of experience in the diagnostics and health care industries. Cory held project coordination, QA management, and manufacturing management positions at 2 companies he worked at from 1984 until 2002 (Genetic Systems, Inc. and Ostex International, Inc.).

At Ostex Cory was responsible for all phases of diagnostic test manufacturing. He managed the design and construction of 2 manufacturing plants, delivering those projects on schedule and within budget. By addressing validation and commissioning requirements during the design process, he ensured that the facilities met all requirements and could be fully validated. By keeping communications between owner and contractors focused and timely, he shortened project timelines and reduced project costs.

Since Cory began consulting in 2003, he has worked for a wide variety of clients including medical device, pharmaceutical, and bio‑pharmaceutical companies.

Cory has served on management teams of start-up companies, helped clients find acceptable contract manufacturers, and managed those vendor relationships as necessary.

He has helped clients with new manufacturing facilities validate those facilities by writing validation master plans, validation protocols, and validation reports.

Cory has written Small Business Innovation Research (SBIR) grants, helped write physician training tools for a medical device company, and designed and implemented the Quality Systems that his clients require. He has also audited and evaluated potential vendors to help his clients choose the most capable suppliers.

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