Heather Tomellini

Npi Quality Engineer Ii @Johnson & Johnson | Vision

Jacksonville, FL, US

Lead quality activities for new product introductions and post-launch design changes for regulated medical devices, ensuring compliance with FDA QSR (21 CFR Part 820) and ISO 13485 requirements. Own and execute design control processes, including development and maintenance of design documentation, traceability, and facilitation of cross-functional design reviews throughout the product lifecycle. Perform and review risk management activities, including clinical and design change risk assessments, mitigation strategies, and risk reporting in alignment with ISO 14971. Serve as quality lead for process validation activities (IQ/OQ/PQ), including development and approval of validation plans, protocols, and final reports for manufacturing processes and equipment. Partner closely with Engineering, Manufacturing, Regulatory Affairs, and Operations teams to integrate quality and regulatory requirements into development timelines while supporting timely product execution. Support continuous improvement initiatives to strengthen quality system processes, enhance audit readiness, and ensure scalable compliance for growing product portfolios.

Worcester Polytechnic Institute

Bachelor of Science (BS), Biomedical Engineering

Worcester Polytechnic Institute

Master of Engineering (MEng), Biomedical Engineering