Description
A Quality Assurance and Regulatory Compliance leader with over 17 years of hands-on experience in Class I, II and Class III cardiovascular medical devices (implantable defibrillators), disposable products, patient monitoring devices, mobile medical devices/apps and combination drug/device products. Held various positions with increasing authority and responsibilities in management and functions which have led to comprehensive understanding and strategic skill set in the following areas: • Manage/Supervise: Have lead and managed manufacturing and quality groups up to 30 individuals (direct and indirect)in two shifts. Lead and influenced larger groups and functions through Catheter line support and sustaining activities. • CAPA/Complaint/Investigations: Experienced in writing and reviewing CAPA/Complaint reports, performing root cause investigations, developing CAPA plans and metrics as well as defining CAPA systems, re-engineering Complaint management process and lead training programs for CAPA and Complaint management systems. • Regulatory Involvement: Direct involvement with FDA, PMDA, MHLW, and Notified Bodies as an Audit Facilitator, Staging Room Lead and Strategist. Lead and developed Inspection Readiness plans, CAPA audit responses to 483s, Warning Letters, follow-up actions. Also direct involvement with MHRA, FDB and customer audits. • Risk Management: Lead product development teams to develop and manage Risk Management Documents (Design FMEA, Use FMEA and PFMEA) to assess patient risks associated with new cardiovascular medical devices (includes Class II, Class III Implantable, and combination drug/device), ensure hazards are mitigated, and that devices are safe for patients and users. • Trainer: Trained staff in CAPA/root causes analysis, Complaint systems, clean room behavior including gowning training, laboratory and manufacturing equipment operation. Developed training modules and lead side wide GMP training to address Notified body observation. • Software/QMS used: Agile, TrackWise, Master Control, ERP system, SAP, and Statistical software - Minitab, Jump.
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