Job TitleQMS Manager
Great innovations start with the people that are passionate and skilled enough to create them. As a diversified health and well-being company, Philips focuses on improving people’s lives through those timely and meaningful innovations.
- Accountable for the transformation of all current QMS’s parts in scope towards the single PQMS structure.
- Accountable to manage and harmonize all QMS management processes and ensure the FDA-compliant validation of all SW systems in scope.
- Manages (local) Q&R processes and ensures (local) process ownership for all activities under the PQMS governance in scope.
- Ensures Q&R requirements are effective in all processes in scope.
- Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope.
We are looking for
The successful candidate will possess the following knowledge, skills education and experience:
- Maintains, enforces, and manages 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 of Health Tech.
- Manages the transition/ deployment of the global PQMS and manage its deployment on the local level.
- Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations.
- Locally manages plan for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of the transition to the global PQMS.
- Ensures the addition and management of any local QMS documents in line with the evolution the PQMS.
- Ensures training and training registration as per the QMS and generates training content for local QMS documents as necessary.
- Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company. Often must lead a cooperative effort among members of a cross functional project team
- Minimum of three years of similar work experience.
- Experience working in disciplined regulated industry and in applying automated technology.
- Experience validating activities for applications especially for their intended uses.
- Experience with business application implementation projects, including being an active contributor on projects with scheduled deliverables.
- Demonstrated ability to understand and develop processes.
- Demonstrated ability to interact and communicate in English, including demonstrable writing, speaking, and comprehension skills; ability to communicate across levels of the organization.
Here at Philips WE ARE Working Together for a Better Tomorrow:
Philips’ dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
Call to Action / Contact
Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.
Ready to start improving lives by putting your personal skills & passions to work?
Find out more info about Philips at www.philips.com/na/careers
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
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