CAPA Manager - UltrasoundJob Description
Effective Wednesday, January 4th, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips. Employees with a sincerely held religious belief and/or disability impacting their ability to obtain the COVID vaccine can request a reasonable accommodation.
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 c ontact 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. You are responsible for
Key areas of responsibilities:
You are part of
- Ensures compliant and effective QMS's are maintained in scope.
- Accountable for the transformation of all current QMS's parts in scope towards the single 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 ensures (local) process ownership for all activities under the PQMS governance in scope.
- Ensures Q&R requirements are effective in all processes in scope
- Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope.
- Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
- Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
- Work effectively with all levels of management to ensure CAPA action plans can be supported and resources needed to implement plans are available.
- Support the CAPA Review Board-Support intake process of CAPA Requests from feeder processes to present to the board & presenting CAPA System Health metrics for monthly reviews. Escalates issues to CAPA Review Board as needed.
- Support and present CAPA during internal and external audits successfully.
- Engage with the Multi-Market CAPA team, and global CAPA Community of Practice to support continuous improvement efforts in the CAPA process.
Philips is one of the world's leading healthcare technology companies. We are committed to understanding the technological and human needs of patients and caregivers and to delivering solutions that enable more confident diagnoses, more efficient delivery of care, and more positive user experiences. People focused. Healthcare simplified. To succeed in this role, you'll need a customer-first attitude and the following:
In return, we offer you
- Bachelor's degree or higher
- 5+ years of related experience in the medical device or another regulated industry.
- Experience with a wide variety of CAPA situations - product, process, complex
- Understanding and application 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), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745 .
- Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
- Analytical Skills; demonstrated ability to troubleshoot complex process/system issues
- High attention to detail, while also being able to take a wider/systemic view
- Demonstrated experience in leading cross-functional teams for problem solving, with excellent team-work spirit.
- Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management
- Executive communication skills; ability to prioritize and manage multiple simultaneous programs/projects
- Experience as an auditor is preferred.
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.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.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?
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 .
Philips Electronics Ltd is committed to treating all people in a way that allows them to maintain their dignity and independence. We welcome and encourage applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.