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 guidelines.

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, and maintained SDLC processes using an iterative approach, including product software risk assessments blending industry best practices (GxP) and the needs of the company > Maintained compliance standards with US and international regulations (IEC 62304, FDA QSR, and ISO 14971)> Developed and conducted training for design control / SDLC for the internal and external SW Design and Development Team> Led software quality improvement efforts to enhance quality systems, resolve quality issues, and mitigate software compliance risk> Managed risk assessment and validation processes for non-product software used throughout the organization > Implemented and validated compliant QMS processes (document control, control of records, training, and various other quality processes) within the current eQMS/PLM, providing traceability and saving company resources

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 approval.> Developed, implemented, and maintained the company’s quality management system (QMS) while ensuring compliance with medical device industry regulations and standards, including FDA QSR, ISO 13485, and Canadian Medical Device Regulation (CMDR) > Led and managed internal and external audits; monitoring and auditing the QMS processes for compliance, effectiveness, and continued alignment with applicable regulatory and statutory requirements, resulting in the renewal of certification> Developed and managed SDLC processes in compliance with IEC 62304, FDA QSR, and ISO 14971, blending industry best practices (GxP) and the needs of the company> Developed and conducted training for design control / SDLC for the external SW Design and Development Team, fully streamlining the process to reflect HMI controls over external suppliers> Managed and coordinated within the organization to formulate and implement practical corrective and preventive actions (CAPA) for internal and external assessments, adverse trends, quality processes, and product issues> Implemented a new hybrid CAPA process that adheres to applicable standards and guidance while integrating within current e-QMS/PLM software

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 in the EU.> Provided tactical direction and guidance to a team of direct reports of software quality engineers and members of product development about design controls for a novel commercial medical device > Developed and implemented best-in-class risk management strategies and programs, including software-focused and cybersecurity risk programs and assessments, ensuring a commendable safety performance record> Developed and managed compliant SDLC processes using an iterative approach resulting in zero high-severity bugs in thirteen software releases and no findings in multiple audits

Malvern, Pa, Us

Malvern, Pa, Us

Raynham, Ma, Us