Sr. Quality System Manager
In this role, you have the opportunity to
- Lead the Quality Management System at Philips Site Zhuhai, ensure that the Quality Management System is in compliance with the appropriate Philips Policies, standards and regulations required by the products supported.
You are responsible for
- Define and maintain the Quality Management System structure to ensure compliance to Philips Policies, ISO 9001, 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 manages its deployment.
- Ensure proper audit planning and schedule meets the requirements of internal policies and external regulations.
- Establish and execute a transition plan for all QMS in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS.
- Lead/participate in the maintenance of the quality documents until such time as they are determined to be no longer applicable as part of the PQMS transition.
- Ensure the addition and management of any local QMS documents in line with the evolution of the PQMS.
- Ensure training and training registration as per the QMS and generates training content for local QMS documents as necessary.
- Manage the transition /deployment of applicable procedures and monitor its implementation Plan, coordinates, and execute internal QMS audits to ensure compliance with internal and external requirements and to identify and implement improvement opportunities within the organization
- Ensure proper planning and schedule of regulatory reporting meets the requirements of internal policies and external regulations.
You are a part of
- Philips Quality Management System- Operations Quality, headquartered in Amsterdam, Philips Personal Health team is made up of a highly talented and multi-national workforce that is approximately of 25,000 strong, and spans over 50 countries with sales in more than 100 countries. You report to Quality Director based on Zhuhai site.
To succeed in this role, you should have the following skills and experience
- Education: Bachelor’s degree in a scientific or technical field Work experience:
- 7+ years of experience in the medical device industry
- Experienced manager with a minimum of 5 years of experience leading teams and delivering on organizational objectives.
- Experience managing a team to deliver business application implementation projects, including experience as an active contributor on projects with scheduled deliverables.
- Experience validating application activities.
- Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
- Successful experience working with cross functional teams across multiple work locations.
- Competencies and Skills
- Strong working knowledge of GMP’s and other US FDA and China FDA regulations
- Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.
- Proven analytical capabilities.
- Strong IT skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications.
- Excellent communication, organizational and project management skills
- Effective written and oral communications skills and computer skills required
- Network oriented and able to interact with different business functions and can work within numerous systems.
- Work cooperatively in a team environment
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.
Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven.
Little did they realize that it would become a global force of innovation, committed to
improving billions of lives worldwide. But it did.
Today, Philips is a world leading health technology company with a vision to make life better
for people worldwide through meaningful innovation. Making good on this promise depends on our
passionate, inspirational, collaborative and diverse team.
We have over 80,000+ brilliant people around the world but are always looking for more.
Like-minded, motivated, focused minds to join us in creating a healthier, more connected society
while tranforming themselves personally and professionally.
Working at Philips is more than a job. It's an experience filled with unexcepted moments that
will transform you in lasting and positive ways. Help us improve the world for the better while
building a career that no one could have planned for. Even you.