As a QMS Manager you have the opportunity to be part of the Diagnostic X-Ray (DXR) Quality Management Team and ensure that the Quality Management System is in compliance with the appropriate Philips Policies, standards and regulations required by the products supported.
Your role:
Define and maintain the Quality Management System structure to ensure compliance to e.g. Philips Policies, ISO 13485, 21 CFR 820, Canadian Medical Devices Regulations (CMDR), EU Medical Device Regulations and China FDA/ Medical Device & GMP Regulations.
Maintain, enforce, and manage a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels.
Establish the Philips Quality Management System (PQMS) and manage its deployment.
Lead/participate in the maintenance of quality documents.
Ensure the addition and management of any local QMS documents in line with the evolution of the PQMS.
Manage software validation of QMS relevant software applications.
Manage the transition/deployment of procedures and monitor its implementation plan. Coordinate internal/external QMS audits to ensure compliance with internal and external requirements and to identify and implement improvement opportunities within the organization.
You are a part of
A passionate team of Quality & Regulatory professionals and an equally passionate Business Unit organization, with a focus on the Health Continuum. Direct, open and swift communication is within our culture to ensure success.
You're the right fit if you have:
Bachelor’s degree plus a minimum of 3 years of related experience in the medical device or another regulated industry
Understanding and application of appropriate global medical device regulations, requirements and standards
Proven experience in Quality Management System processes
An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
Advanced Analytical Skills; demonstrated ability to troubleshoot complex process/system issues
Strong communication skills; ability to prioritize and manage multiple simultaneous programs/projects
Strong IT Skills
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
This is an office - based role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
