Maddalena Pieri

Principal Quality Engineer @Mozarc Medical

Mirandola, IT

I\'m a Principal Design Quality Engineer, in this last two years I\'m working on a project in early development phasewith the role of Quality Eng. team leader, leading a Design Quality Engineer team for their activities and as mainpoint of contact for all project stakeholders.In the day by day work my activities are:• Design Control and Design Change along Medical Device lifecycle (active and non active class IIa and IIb):support and review of all R&D deliverable for developing and maintenance of DHF in accordance toapplicable standards and Regulations (Planning, Design Input, Design Output, V&V Testing, DesignTransfer).• Support to R&D and Manufacturing Engineering in the implementation of DRM best practices in the day-lifeof the projects.• Management of Risk Management Process: from Plan to report using tool like PHA and FMEA.• Management of Standard compliance Process (applicable standard list, monitoring, applicability, evidence ofcompliance check) for medical device class IIa and IIb active and non active• Use of statistical tools to determine simple size, support the team in analysis of control, Montecarlosimulation and Design of Experiment.• Support to Quality Management System for continuous improvement in conformity to applicable QualitySystem requirements and regulations (ISO 9001:2015, ISO 13485, FDA 21CFR820, MDSAP requirements).• creation of a unique QMS along the company (standardize and simplify)• write procedures / instructions 7 forms on Design Control, Design Change, Risk Analysis, StandardCompliance• Support to RA for product submission process and interactions with Notified bodies (TUV, FDA)• Support to clinical team for Clinical Evaluation deliverables.• I take part to third part audit (ISO 13485, ANVISA, MDSAP, CSA).• I’m qualified as Lead Auditor (40 hours training ISO 19011) and I regularly perform internal Audit.• Mentoring of DQE team member supporting their growth