ResponsibilitiesManages the QMS transition of the PQMS/PEPF and manage its deployment in the Markets. Locally manages plans for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS. This includes the drafting of transition plans, execution of gap assessment against current QMS’s, action setting and follow-up on actions. Ensures the addition and management of any local QMS documents are in line with the evolution of the PEPF and the PQMS. Work with (Local) Business Process Owners, Business Process Experts, Market Deployment team, E2E Q&R and local Q&R in order to manage PEPF and PQMS deployments
Requirements• Experience working in disciplined regulated industry and in applying automated technology. • Seasoned knowledge of ISO 9001 and ISO 13485 (preferable including ISO 9001:2015 and ISO 13485:2016) • Strong analytic skills • Demonstrated ability to understand and develop processes. • Excellent organizational and Project management skills with an attention to detail and follow-through • Professional English written and verbal communication skills • Ability to influence others to achieving goals • Ability to work under a minimum of supervision • Hands-on mentality
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Robin Hiariej.