In this role, you have the opportunity to
Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology. This role is a perfect opportunity to develop skills you skills, knowledge and exposure to be able to grow into a Quality Systems leader or Project owner.
You are responsible for
•Maintain a compliant and effective QMS for the activities in scope (including, but not limited to addressing compliance deficiencies) as well as for effective and lean QMS structure and documents for Q&R processes in scope
•Effective (local) expert role for Training Administration processes and tools in scope
•Ensure the assignment of training requirements profiles and documentation for all job' required training
•Ensure that managers assign the correct training profiles to all individual employees based on job requirement profiles
•Provide feedback to users on profile and training compliance and noncompliance
•Recommend and drive items to demonstrate training effectiveness improvements
•Enable the transition/deployment of the PQMS and manages its deployment
•Administers and contributes to the management of any local QMS documents in line with the evolution of the Philips Excellence Process Framework and the PQMS
•Manage compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies in scope are consistent with those regulations.
•Manage (local) Q&R processes in scope and ensures Q&R requirements are effective in all processes in scope.
•Ensure external and internal audit readiness and provides support during external and internal audits
•Participate in Quality & Regulatory initiatives as a cross functional contributor
•Demonstrate operational excellence and ensure quality in all deliverables
You are a part of
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and the leadership. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
This role will report to the Head of Philips Quality Management System for Emergency Care & Resuscitation
To succeed in this role, you should have the following skills and experience
•Bachelor's degree, preferable in engineering, plus a minimum of 2 years of related experience in the medical device or other regulated industry
• Understanding of appropriate global medical device regulations, requirements and standards, including FDA's 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), ISO 14971, ISO 9001, and others strongly preferred
•Experience in Quality Management Process preferred
•Government/regulatory-body Quality System auditing/inspection experience preferred
•Demonstrates considerable knowledge of, and success with performing on, compliance-related projects
•A comprehensive understanding of the diverse worldwide medical device quality regulations strongly preferred
•An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
•Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor
•Attention to detail
•Solid organizational and interpersonal skills
•Ability to analyze information and come to conclusions based on presented data
•Ability to communicate effectively both orally and in writing
•Manage time working on multiple projects simultaneously
•Open to other's ideas and working collaboratively across functions and/or businesses
In return, we offer you
Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
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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