ABOUT
"Product design and manufacturing in a regulated industry is not about what you know you did, it's all about what you can prove you did. The proof comes from the right people, using the right process, and creating defendable documentation"
Robert Sestrick
Founder and Principal
I am a leader that bridges medical device quality and regulatory requirements to operational excellence. A strategic partner and coach with strong expertise in the application of domestic and international quality system regulations. Known for developing synergistic partnerships with other leaders to balance operational decisions with quality and regulatory requirements. Able to think cross-functionally by applying expertise gained from large global to start-up medical device companies in the areas of quality, engineering and manufacturing. Valued as a change agent passionate for converting challenges to opportunities by infusing simplicity into solutions to drive continuous improvement throughout the organization.
► QUALITY SYSTEMS: Accomplished in establishing and maturing quality systems in compliance with cGMPs and ISO 13485. Led projects within 21 CFR 803, 21 CFR 806, 21 CFR 810 and 21 CFR 820 to identify and systemically reduce compliance risk profile.
► QUALITY ENGINEERING: Leverages BSEE and experience in device manufacturing to lead quality engineering efforts for Class I to Class III medical devices. Skilled practitioner, trainer and lecturer in Design Controls, Document Controls, Production & Process Controls, CAPA and Purchasing & Supplier Controls assuring compliance, repeatability and efficiency are at the core of all solutions.
► QUALITY AUDITING: ASQ Certified Biomedical Auditor (CBA) and past CBA Exam Chair. Established auditing procedures and trained internal auditors in best practices. Subject matter expert utilized to assure compliance from performing mock audits in preparation for FDA Inspections to comprehensive design history file audits to support a market release decisions.