Director of QMS, North America
Job TitleDirector of QMS, North America
Job DescriptionIf you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance. Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.
The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs. In this role, you have the opportunity to make life better Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.
This is a strategic role with a focus on people management and strategy development.
The responsibilities for this role are to coach, guide, and assist the QMS Managers on the creation, development, implementation, and maintenance of effective QMS's to enable the businesses. A key aspect of this role will be to create hubs/Centers of Excellence across North America in the areas of CAPA, NPSS, training, and doc control to assure we have a flexible group which can work across sites within the region. You are responsible for
- Managing a remote based team based in North America. The Director of QMS will be responsible for leading, influencing, and creating a successful team culture.
- Ensuring complaint and effective QMS’s are maintained in scope.
- Accountable for the transformation of all current QMS’s parts in scope towards the single Philips QMS (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 ensure (local) process ownership for all activities under the PQMS governance in scope.
- Ensure Q&R requirements are effective in all process in scope.
- Ensure Document Control is established and ensure training profiles are assigned and enforced and training administration is established within scope.
- Work closely with the formal owner of the QMS (e.g., site/business manager or process line management).
- 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 HT.
- Establishes the PQMS and manages its deployment.
- Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations.
- Establishes and executes a transition plan for all QMS in scope while maintaining compliance and effectiveness throughout the duration of the transition to the QMS.
- Leads/participates in the maintenance of the PQMS documents until such time as they are determined to be no longer applicable as part of the QMS transition.
- Manages the addition and maintenance of any local QMS Documents in line with QMS management procedures.
- Ensures training and training registration as per the QMS and generates training content for local QMS documents as necessary.
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- Bachelor’s degree in Life Sciences, Engineering, or relevant discipline. Masters desired.
- Project Management Certification desirable.
- 10+ years of experience in Medical Device Industry focusing within the Quality and Regulatory function.
- 5+ years of demonstrated experience leading and managing a team- including supporting remote based teams across North America.
- Project management experience leading complex projects where not directly responsible for all required deliverables.
- Technical experience with systems used to automate quality system processes- in the medical device industry.
- Excellent understanding of the Quality Systems Regulation (ISO 9001, ISO 13485, 21 CFR Parts 803/806/820)
- Proven ability to work and lead a team in a matrix organization
- Demonstrated ability to successfully collaborate with stakeholders and drive global transformation projects. Including supporting Leadership and upper management.
- Proven ability to take independent action to initiate process improvement.
- Proven ability to deliver on delegated work efficiently.
We know just how important direct interactions are and work is more engaging when we are more frequently face-to-face, and that we experience better collaboration which drives innovation. While we have many different types of roles across Philips most require a combination of in-person collaboration with colleagues and partners, usually at a Philips location, and individual focus time, which can be done remotely. 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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
Visit our careers website to explore what it’s like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some 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 race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws. 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. Equal Employment and Opportunity Employer/Disabled/Veteran #LI-PH1 #LI-Remote
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