Liz Adams Email & Phone Number

United States

Responsible for the build out of the entire Quality Management System which provides oversight of activities from concept through commercialization of IVD products for the US market Participating in strategic planning for R&D, clinical trial, 510(k) FDA submission, and commercializationGuide engineering, research and development, operations, and software.

Lead a team of Quality Engineers to develop and grow a Quality Management System that was appropriate for the size and stage of the company from early concept through commercialization including Design Controls, supplier management, continuous improvement (CAPA, NCR, SCAR, Complaints), installation and servicing, design assurance, verification and.

Lead the Quality and Regulatory group, overseeing both commercial production and new product development.

Watertown, MA

Quality lead for internal product development team and integrated OEM development team. Develop and implement quality systems compliant to ISO 13485:2003 and 21 CFR 820. Support regulatory submissions to FDA, TGA, and various European Geographies. Championed design deliverables for regulatory submission with an abbreviated timeline. Host to third party.

Member of quality team supporting internal product development team and integrated OEM development team. Developed and implemented quality systems compliant to ISO 13485:2003 and 21 CFR 820. Supported regulatory submissions to TGA and various European Geographies. Performed internal audits.

Bedford, MA

Quality/technical reviewer on all technical documents for device and pharmaceutical products for compliance with 21 CFR 210, 21 CFR 211, 21 CFR 820, ISO 13485, and Medical Device Directive (MedDev). Documents include design verification and validation protocols and reports; biocompatibility and toxicology reports; Investigational Device Exemption (IDE).

I was the lead designer on product modifications on a product line. In this role, I was responsible for designing the modifications, documenting the changes using ISO 9000 procedures and FDA guidelines, implementing the changes on the manufacturing floor, and working with the Sales and Marketing division to best market the improved product. I also wrote.

Intern responsible for test method revisions in compliance with FDA standards. Retested current market products to validate according to FDA standards. Created test fixtures using Solid Works and wrote corresponding test methods and released into internal documentation system.

Compiled all previous data from project team into usable documents. Created test method to test product material for pushability. Conducted material tests using radio frequency welder and tensile testing machine.