Head of Quality - IGTD
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Senior Director, Quality for IGTD 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 sophisticated 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.
Lead and implement the Quality strategy and team for the Devices business in IGT cluster.
Your responsibility will be to guide and support the Business Management Team (MT) of the fast growing devices business to improve product quality and compliance to exceed customer expectations. This involves being a confident and effective communicator on sophisticated quality and regulatory compliance matters, global regulations and quality management related topics, and product knowledge.
You are responsible for
You are part of
- Execute a single aligned quality strategy that is forward looking and supports business growth, compliance, improved product quality and customer experience.
- Acts as a key influence and change agent on the Business Management Team and optimally work with the cross-functional leadership team to improve quality and compliance outcomes.
- Act as the management representative for all key regulatory agencies for product safety and quality (e.g: US FDA, EU MDR, TGA, MHLW, NMPA, etc.). Develop and maintain an effective working relationship with US FDA and other international regulatory bodies.
- Proactively ensure all facilities and functions (I2M, O2C) consistently operate in a state of compliance and inspection readiness; proactively ensure all products, software, services and systems requirement meet global quality and regulatory requirements.
- Lead, collaborate and partner with Site Quality leaders, Business MT, Philips Central teams, Markets and functions on critical initiatives and transformations.
- Establish the vision and strategy to complete quality systems such that the QMS is compliant, effective and efficient for IGT-D business. Assure consistent and standardized execution of Philips Excellence Process Framework (PEPF) processes.
- Provides leadership to the quality team to drive common goals and objectives that improve customer experience, operational excellence & proactive regulatory compliance.
Consists of members of the Quality & Regulatory Organization and directly reports to the Head of Quality for IGT.To succeed in this role, you'll need a customer-first attitude and the following
In return, we offer you
- Degree in Engineering or Science, a Master's degree would be a distinct advantage
- 15+ years global medical device industry with significant class 3 proven experience
- Strong leadership skills and the ability to function well within a matrix organization
- Leadership experience in various aspects of Quality, such as design quality, quality systems, post market surveillance and internal / external audit representation
- Experience in establishing Quality strategy, oversight, Quality systems, etc. preferably at group/corporate level in a large multi-national company
- Relevant training, experience and certification (ASQ Quality Manager, Auditor, Six Sigma, etc.), Continuous Improvement methodologies and Quality tools such as Lean, Six Sigma, 5 Why's, Fishbone, etc.
- Extensive experience in Quality system metrics through use of leading indicators to drive high performing systems and teams.
- Strong program management skills with a consistent record of accomplishment of leading key compliance programs through direct and/or indirect line management.
- Experienced knowledge of global medical device regulations, requirements, and standards, such as FDA, ISO13485, ISO14971, EUMDR.
- Familiar with business process management frameworks including best industry practices as it pertains to QMS
- Highly collaborative doer who is an effective communicator and relation builder/ networker
- Proven track record to lead cross-functional, diverse teams with ambitious goals
- This role can be located in San Diego, CA, Denver, CO, Cambridge, MA or Minneapolis, NM
- Willing to travel up to 25%
The ability to collaborate with, learn and grow from colleagues in a highly sophisticated, global organization where you can use your strengths to help drive strategic business initiatives for Philips. Additionally, we provide you a dynamic working environment in an innovative business, paired with a competitive salary, excellent benefits, and a supportive atmosphere where you can sharpen your talents with new challenges and career opportunities. How we work at Philips
There are three core ways that define our ways of working - embracing flexibility, being at our best, and impactful collaboration . We believe this enables us to deliver an outstanding experience to our customers and create the best place to work for people who share our passion.
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.
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