Quality System Business Process Expert
The Quality System Business Process Expert supports the development, deployment and maintenance of the Philips Quality Management System (PQMS), ensuring Philips cross sector standardization and regulatory compliance.
Together with a cross functional project team you will work on the roll out of End-to-End (E2E) processes and software applications from the Philips Integrated Landscape (PIL), ensuring compliance to regulations is maintained throughout the project.
Eindhoven, Netherlands with potential travel to Amsterdam, Netherlands
• Support E2E Programs and business / market PQMS teams with the deployment of E2E processes and PIL software applications
• Support the E2E Programs to ensure E2E process content and validated software applications are available in time to meet deployment timelines
• Ensure QMS deliverables are embedded in the project plans to ensure compliance to regulations.
• Keep oversight of deployment projects and ensure E2E process content, validated software applications and QMS deployment deliverables will be available per the agreed schedule, escalate (possible) delays.
• Support business / market PQMS teams with timely completion of impact assessments, identification of appropriate Q&R activities and closure of defined actions
• Support business / market PQMS teams to maintain oversight of scheduled projects
• Provide visibility on PEPF QMS Deployment statuses and Project Deployment Readiness.
• Quality Assurance is an integral aspect of the global healthcare business including device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance. This position is intimately involved in the process of ensuring Quality System Regulations are embedded within business processes and supports the standardization of the Philips Quality Management System.
• Bachelor’s degree or equivalent preferably in a scientific discipline
• Minimum of 7 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting multiple functional disciplines within a global medical (device/Pharma) industry.
• Proven experience in Quality Management System processes, including cross sector or business process standardization (desired), ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations.
• A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance.
o This position requires an extensive knowledge of FDA QSR’s, ISO 13485, GMP’s and other worldwide Quality System Regulations.
• An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
• Experience with deployment of Quality Management System processes as identified
• Skill set required for the department to operate:
o Project management experience
o Good communication skills written & verbal in English
o Demonstrated experience in collaborative working environments
o Experience addressing conflicts, escalation at team level to achieve desired results.
o Demonstrated experience handling deadlines, able to focus on targets
o Demonstrated experience-driving progress, taking initiative to achieve results.
o Experience understanding the process approach ‘End-to-End’, where, the optimization of customer value chain starts from ‘customer insight’ all the way to delivering products & service to the customers.
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