Steve Zera
Steve Zera is a Senior Operations, Quality, and Enterprise Excellence Transformation leader with 25+ years of global manufacturing experience in the Medical Device (Class I, II, & III) and Pharmaceutical (API, Aseptic, Solid Dosage) industries. He has held leadership roles with Medtronic, Covidien, Mallinckrodt, Tyco Healthcare, and the Medical Device Innovation Consortium.
Throughout his career, Steve has driven Operational Excellence, Quality System, Quality Culture, and Digital Transformation initiatives, delivering measurable improvements in performance, compliance, and cost efficiency across global manufacturing sites, acquisitions, contract manufacturers, and suppliers. He co-developed a Quality Culture improvement program called “Quality Begins with Me”, which was shared with both the industry and FDA as a best practice for advancing quality culture in regulated environments.
Most recently, Steve collaborated with CDRH and FDA to accelerate adoption of AI, Digital Twin/Thread, and Digital QMS technologies, enabling Industry 4.0 and Total Product Life Cycle (TPLC) digital strategies within the Medical Device and Life Sciences sectors. He contributed to the publication of a Digital Transformation research study, as well as two industry use cases on Digital QMS and Digital Twins.
A skilled communicator and change leader, Steve has successfully partnered with stakeholders at all levels—from C-Suite executives to shop-floor teams—to solve complex challenges and guide large-scale transformations.
He holds a BS in Mechanical Engineering from Virginia Tech, is a certified Project Management Professional (PMP), and holds Lean Manufacturing and Six Sigma (Black & Green Belt) certifications.
