Ann Rossi Email & Phone Number

Established an independent consulting firm providing services for companies in the life science industry (medical devices/pharmaceutical) in the related areas of QMS and Software Quality Assurance. Ability to meet strict project timelines, coordinate with and software design/quality engineers, and deliver quality controls in adherence to all FDA and EU.

Waltham, Massachusetts, US

Defined and implemented the strategic vision for product and non-product software QA while leading, coaching, mentoring, and growing a direct report team of software quality engineers. Led review of software development plans, software engineering specifications, design documentation, verification plans, protocols, and reports. > Developed, implemented.

Newtown, Pennsylvania, US

Provided direction and guidance to internal direct reports and outsourced members of quality assurance and product development teams about design controls for a medical device commercially distributed in Canada. Acted as a critical contributor to the De Novo submission after approval of Breakthrough Device Designation providing the pathway to FDA.

Lexington, MA, US

Lexington, MA, US

Established strategic vision and direction for Design Assurance Engineering, including the development of a robust Human Factors / Usability Engineering (HF/UE) process in compliance with EU and US regulatory requirements, ensuring patient and user safety from early-stage product development through post-market surveillance resulting in successful CE Mark.

Malvern, PA, US

Malvern, PA, US

Raynham, MA, US