Rosalee Celis

About Rosalee Celis

Quality System Manager at Philips, Emergency Care and Resuscitation.

Experience

1. Quality System Manager

   Philips

   Jun 2020 — Present

   Quality System Manager for the Emergency Care & Resuscitation business (Class defibrillators). Program Manager for Emergency Care Quality Norm- Manage all Quality Norm activities by acting as the intermediary between the business and corporate teams, implementing business-level changes to the Quality Norm program, and coordinating stakeholder participation to meet program ambitions- Prepare presentations to the Philips Executive Committee for deep dives on Quality Norm performance, Cost of Non-Quality reduction initiatives, and product portfolio management- Host cadence with the business Leadership Team to review Quality Norm performance Audit Experiences- Act as backroom lead or front room host for internal and external audits/inspections - Facilitate cross-functional participation to ensure efficient support in the backroom - Provide quality reviews in the backroom to ensure responses are adequate - Act as a key quality member post-audit/inspection to provide responses for findings - Experienced with external audits for EU MDR, MDSAP, ISO 13485, FDA, and Brazil INMETRO General QMS Responsibilities- Lead QMS member to oversee the transition to EU MDR 2017/745 - Lead QMS member to oversee QMS Quality Plans across all functions - Provide project management for QMS-owned quality plans - Provide QMS support for process updates or record remediations - Provide QMS support for CAPAs during investigations and implementations

Skills

• Market Research
• Medical Device R&D
• Six Sigma
• Consumer Products
• Test Method Development
• Minitab
• Data Analysis
• Failure Mode and Effects Analysis (Fmea)
• Materials R&D