Steven Tufo
Manager of Compliance at Foresight Imaging
- Role
- Manager of Compliance at Foresight Imaging, Llc
- Location
- North Andover, MA, US
- LinkedIn followers
- 500 followers
About Steven Tufo
A product and people manager with over 12 years’ experience in the software and pharmaceutical industry. Held leadership positions working closely with software developers, validation engineers, project managers, marketing professionals, medical writers, and customers in FDA regulated, GxP, and 21 CFR Part 11 compliant environments. Managed eight member hybrid onsite/offshore engineering team. Owned and managed products from inception to market launch. Developed various documents for the software development lifecycle including SOPs, product roadmaps, technical specifications, software requirements, user stories, validation plans, etc. Led roadmap planning sessions, requirements workshops, engineering review boards, prioritization meetings, and vendor qualifications. Prepared for and participated in pharmaceutical client and FDA audits.
Experience
Manager of Compliance
May 2019 — Present
Maintained the full quality management system for the organization - Internal Audits, Quality Manual, Procedures, CAPAs, Work Instructions, Quality Records• Ensured the business remains compliant with all applicable medical device regulation including ISO 13485, FDA CFR, EU MDR, and Canadian MDEL• Represented the company in audits by notified bodies and regulatory agencies• Lead Management Review meetings
Education
Worcester Polytechnic Institute
Bachelor of Science (BS) with distinction, Manufacturing Engineering, GPA 3.5
2001 — 2005
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.