Jonathan Severino Email & Phone Number

Bethlehem, Pa, Us

- Established and implemented corporate wide post market surveillance system covering a broad range of medical devices, pharmaceutical/medicinal products, and combination products including, but not limited to, orthopedic implants/instruments; infusion pumps; dialysis equipment; parenteral drugs; parenteral nutrition; convenience kits; and pre-filled syringes.- Leading a diverse team of engineering, clinical, and risk professionals dedicated to continuously enhancing and improving the quality, safety, and effectiveness of medical products while adapting to a changing landscape of regulations, consumer needs, and business environments.

Bethlehem, Pa, Us

- Developed and implemented multi-site post market surveillance system covering a broad range of medical devices, pharmaceuticals/medicinal products, and combination products improving overall regulatory compliance while streamlining processes and reducing overhead costs. - Extensive experience with implementing requirements of post market surveillance regulations including, but not limited to, 21 CFR 806; 21 CFR 803; 21 CFR 314; 21 CFR 820.198; 21 CFR 211.198; Regulation (EU) 2017/745; Regulation (EU) 1235/2010; as well as applicable guidance and standards (e.g. ICH, ISO 13485/1971).

Bethlehem, Pa, Us

Bethlehem, Pa, Us

Bethlehem, Pa, Us

- Supervised six (6) quality control inspectors and served as technical advisor to two (2) quality engineers in an ISO 9001, AS9100, TS 16949 certified quality management system- Lead quality improvement kaizens to reduce incoming inspection lead times from 14 days to 3 days and past due calibrations by 96%- Developed inspection test plans, conducted internal and audits, performed annual employee reviews, lead MRB activities, performed root cause analysis and implemented corrective actions and maintained supplier quality requirements manuals- Developed supplier scorecard system, supplier newsletter, and lead supplier quality system audits to drive quality improvement throughout the supply chain- Served as core team member for implementation of new Enterprise Resource Planning software which incorporated electronic inspection records, nonconforming material reports, and CAPA activities

- Supervised seven (7) inspectors in ISO 9001 and AS9100 certified quality management system.- Drove quality improvement initiatives to reduce past due AS9102 First Article Inspections to zero (0)- Ensured timely resolution of corrective action requests, discrepant material reports, internal audits and audit observations