Director of Quality & Compliance
Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips. Employees may request a reasonable accommodation. Montana employees are currently excluded from this requirement at this time.
If 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:
Exciting opportunity to play a critical leadership role in ensuring Philips Sleep & Respiratory Care, Quality Management Systems (QMS) teams and programs attain the highest level of compliance, effectiveness, and efficiency.
You are responsible for:
You are a part of:
- Direct, lead, and develop the Sleep & Respiratory Care team in a manner aligned with the Philips Quality Management Systems function.
- Identify, track, and plan for continuous improvement of the critical metrics associated with the Philips Quality Management Systems enabling function.
- Lead all aspects of the QMS functions for QMS Management Control
- Participate in building, deploying, managing, and continuously improving the associated processes.
- Sustain the Sleep & Respiratory Care quality management systems to ensure continued compliance with regulations and standards by focusing on areas of responsibility identified for the PQMS.
- Driving and managing relevant Intellectual Property strategy & expectations.
- Formulating and implementing the Business' long-range quality, regulatory and compliance policy; introducing and implementing the quality processes and tools required to ensure product quality and customer satisfaction; and managing compliance to FDA regulations and other regulatory agency regulations and standards.
Philips' Connected Care products and solutions are scalable, secure, and an interoperable health information management portfolio featuring AI-powered smart enterprise systems, devices, software, and services. Integrated solutions seamlessly connect people, technology, and data to support clinical decisions at every point of care. Innovative solutions help customers deliver on the quadruple aim to improve health outcomes, patient and staff experiences and reduce cost of care. We are highly dynamic, ambitious, and agile organization with a mission to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions. To succeed in this role, you'll need a customer-first attitude and the following:
In return, we offer you:
- Minimum of a Bachelor's degree, preferably in a Quality, Regulatory or Life-Science discipline, Master's degree preferred.
- Minimum of 10+ years' experience working in the FDA regulated Medical Device Industry, with 5+ years in a functional/strategic leadership role.
- Proven experience leading, formulating, and implementing global strategies for a multi-site, global healthcare business to ensure compliance with worldwide regulations to improve product market access.
- Confirmed experience to lead and develop strategies for a multi-site, global healthcare business while also being able to design and execute specific projects and lead teams.
- Quality subject matter expert who can lead multiple workstreams, host external auditors and implement process improvements in a high-paced environment.
- Technical experience with systems used to automate quality system processes.
- Strong understanding of Quality System Regulations ISO 9001, ISO 13485, 21 CFR Parts 803,806 and 820.
- Ability to work closely with senior management. Confirmed ability to take independent action for process improvement.
- * US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities. How we work at Philips
Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart - which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home - for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways: We believe in the importance of impactful collaboration
: There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving. We embrace flexibility:
Choosing where, when, and how to work can vary according to task and team schedules. Flexibility isn't office or online, it means choosing the space that works best for you, your teams, and our customers on a case-by-case basis. We want to be at our best:
The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips?
Philips is a global leader in health technology, committed to improving 2.5 billion of lives worldwide and striving to make the world healthier and more sustainable through meaningful innovation. Driven by the vision of a better tomorrow. But it's not just what we do, it's who we are. We are 75,000, 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. #LI-PH1
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.Found this job inappropriate? Report to us