Jennifer Almy has over 15 years of experience in engineering, with 18 years working in medical device and combination product companies performing product design, project management, quality engineering and quality system development and maintenance. She has worked on Class I, II and III products including angioplasty guidewires and balloon catheters, angiogenesis drug delivery devices, biopsy devices for breast cancer and collagen markers, RF and Doppler catheters for pulmonary medicine, endoscopic surgery catheters, implantable biosensors, implantable drug delivery devices, ophthalmic devices, respiratory monitors, pain management devices, and biologics.
Jennifer’s expertise is in creating quality systems compliant to FDA’s Quality System Regulation and ISO 13485 for small companies. She is also proficient in the areas of corrective and preventive action, internal and supplier audits, quality engineering, design control, sterilization, and complaint handling. Jennifer also has Operations experience in inventory control, receiving, purchasing, and production management.
Jennifer started her career in R&D and quickly moved into project management, eagerly transitioning into Quality and managing the Quality System. She has led many start-up companies through the transition phases from feasibility through product launch and created many quality systems to fit the current stage of the company.
Jennifer currently serves as Secretary on the Planning Board for American Society for Quality's (ASQ) New England Biomedical Discussion Group. She is a past Co-Chair for American Society for Quality's Northern California Biomedical Discussion Group Planning Board.
Jennifer received her BS in mechanical engineering, with an emphasis in Biomed, from Worcester Polytechnic Institute. She received her RABQSA Internal Auditor certification.