In this role you will prepare and execute the global Q&R policy by initiating and coordinating related activities throughout all disciplines in order to make Philips a premier organization within the safety & compliance space. You will also develop organizational policies and authorize their implementation while also providing direction to senior managers in various areas, groups, and/or operations.
You are responsible for
Building and deploying a single aligned strategy in Quality & Regulatory Compliance
Acting as the management representative for all key regulatory agencies for product safety and quality (e.g: US FDA, China FDA)
Developing and maintaining an effective working relationship with US FDA and other international regulatory bodies
Actively ensuring all auditable facilities (e.g: manufacturing, innovation, distribution etc.) consistently operate in a state of compliance and inspection Quality Management readiness
Ensuring all products, software, services & systems meet requirements
Establishing the vision and strategy for business management & quality systems/practices to ensure consistent, standardized execution of our Philips Excellence Process Framework processes
Establishing a strong core Q&R team and driving common goals and objectives to result in improved customer experience, operational excellence & dedicated regulatory compliance
Driving ambition towards our vision, act as a coach and co-own the career development plans of your team members
To succeed in this role, you should have the following skills and experience
MS Degree required, PhD preferred
15+ years medical device industry preferred. Will also consider experience from another highly regulated environment (i.e. Automotive, Aerospace, etc…)
Leadership experience in various aspects of Q&R (including internal and external representation on Q&R) AND preferably in at least one operating process domain (Product Development, Supply Chain, etc…)
Experience in establishing Q&R strategy, oversight, Quality systems, etc… preferably at group/corporate level in a large multinational company
Familiar with business process management framework including industry practices such as APQC
Relevant training, experience and certification in Continuous Improvement practices such as Lean/Six Sigma highly preferred
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. Learn more by watching this video.
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.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.