Paul Chiappetta

Background

About Paul Chiappetta

To Contact me: Cell Phone - 908-672-8913 chiappetta.paul@gmail.com Quality Assurance Professional with significant experience in the Medical Device industry with 10 years in a leadership role. Experience includes: Quality Leadership – Collaborative team leader focused on employee growth and shared vision. Quality Systems Implementation – Gap assessment and Implementation of the Quality System Regulation (QSR), ISO 13485 and other medical device related standards including In-vitro devices/companion diagnostics. Continuous Improvement – Extensive experience incorporating Six Sigma and related Total Quality Management (TQM) methodologies within Quality Systems. Design Assurance and Design Controls - Implementation of systems and procedures which exceed current QSR and ISO 13485 requirements. Post Market Surveillance – Incorporating total product life cycle from design to customer experience. Supplier Controls - Systems and procedures which ensure appropriate supplier controls through metric-based performance evaluation while significantly lowering material acquisition cost. Process Validation - Systems and procedures which allow for robust validation and integration of lean change control. Software Validation – Systems and procedures following AGILE principles. Including Cybersecurity methodologies. Compliance - Internal Auditing systems and tools to prepare manufacturing facilities for 3rd party audits and ensure facility wide compliance. This includes MDR and IVDR product/system compliance. CAPA - Robust systems capable of early detection of quality problems, lean based action plans and robust procedures and protocols for FDA and Notified Body audit reviews. Notable experience includes: 1) creating and delivering a corporate Quality System framework for all medical device manufacturing sites within the Thermo Fisher Scientific manufacturing network to adopt. 2) quality system remediation as part of a warning letter to Boston Scientific Corporation through internal site audits and creation of actions plans for audit findings. Subject Matter Expert includes: Leading and mentoring quality professionals as part of company strategies. Performing and facilitating internal/external audits. Implementation of Quality system updates, Consent decree/483 remediation, MDR/IVDR quality system/product compliance, End to end software validation, project management and risk management.