· Acts as Program Manager for PQMS/PEPF and EU MDR deployments in the Market organization, providing status updates to relevant stakeholders in a timely manner
· Manages the QMS transition of the PQMS/PEPF and EU MDR and manage the deployments in the Market organizations.
· Locally manages plans for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of the transition to the Market OneQMS. This includes the drafting transition plans, execution of gap assessment against current QMS’s, action setting, follow-up on actions and closure of QMS Transition Plans.
· Ensures the creation and management of any local QMS documents are in line with the evolution of the PEPF, the PQMS and EU MDR requirements.
· Work with (Local) Business Process Owners, Business Process Experts, Market Deployment team, E2E Q&R, local Q&R and EU MDR Work Streams in order to manage PEPF, PQMS and EU MDR deployments
· Follows processes and operational policies in selecting methods and techniques for obtaining solutions
· Acts as advisor to subordinates to meet schedules and/or solve problems
Must have items
· Excellent organizational and Program/Project management skills with an attention to detail and follow-through
· Seasoned knowledge of ISO 9001 and ISO 13485 (preferable ISO 9001:2015 and ISO 13485:2016)
· Knowledge of MDD and EU MDR/IVDR
· Experience working in disciplined regulated industry and in applying automated technology.
· Strong analytic skills
· Demonstrated ability to understand and develop processes.
· Professional English written and verbal communication skills
· Ability to influence others to achieving goals
· Ability to work under a minimum of supervision
Nice to have items:
· Minimum of five years of similar work experience.
· Has a complete knowledge of company products and services