Frank Meledandri

About Frank Meledandri

Strategic Quality Leader with over 21 years of experience driving enterprise-wide transformation within global medical device organizations. Demonstrated success in designing and executing multi-year strategic roadmaps to harmonize complex Quality Management Systems, enhance regulatory compliance, and implement modern, risk-based validation methodologies, including Computer Software Assurance. Recognized contributor to FDA guidance development and a key leader in digital quality system integration initiatives. Adept at building and leading high-performing teams, fostering cross-functional collaboration, and delivering continuous improvement through Lean principles. Possesses deep expertise across the full lifecycle of quality system processes, with a strong emphasis on strategic alignment, operational excellence, and innovation.Core competencies include• QMS development and consolidation across multiple business units with 190+ Site locations.• Leadership across multiple sites US and International Based. Strong Track record of hiring and developing talent.• PC literacy: SaaS PLM / ERP Software Siemens Teamcenter, Polarion, Track Wise, AGILE, SAP, CAMSTAR, Epicor• FDA – Industry Computer Software Assurance (CSA) team member which helped drive the content in the new FDA CSA Draft Guidance Document. Multiple speaking engagements with the FDA – Industry CSA team, including an FDA invitation to speak at the October 10th, 2017, Excellent Communicator.• MDIC AMCH: Medical Device Innovation Consortium Advanced Manufacturing Clearing House / FDA• Strong network with FDA and closely integrated consultants for developed and implemented solutions.• Strong Passionate Leader of Change / Leading Others / Cross Functional Team Builder / Personal Team Development• Metrics Driven Results / Understanding Customer Needs.(Internal / External)• Quality System Management. Class Medical Device.• FDA Premarket Approval and 510(k) Clearance Device Submissions / management.• Management and Continuous improvement of Quality System Manual• ISO 13485:2016 / CFR 820 / EU MDR / MDSAP / MDDAP / CMMI auditing compliance programs.• FDA Case for Quality Program Industry Development and Implementation Team Member.• Complaint Handling Management, compliance and MDR reporting processes.• Management Responsibility and Review• Field Action Management, coordination of field actions including recalls, corrections, removals, and notifications.

Experience

1. Global Process Owner - Documentation and Change Controls - Quality Management

   BD

   Nov 2025 — Present · Franklin Lakes, NJ, US

Education

• Waynesburg University

  Master of Business Administration (MBA), Project Management

  2012 — 2014

• Penn State University

  Bachlor of Science, Industrial Engineering

  1996 — 2001