Senior Corrections & Removals SpecialistJob Description 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. 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.
Montana employees are currently excluded from this requirement at this time.
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 position for an experienced medical device Quality Assurance Professional who, under supervision, will be a Senior Corrections and Removals Specialist performing various Post Market functions related to recall reporting, tracking, and process execution. This position will support the Sleep and Respiratory Care (SRC) business and Philips markets as a liaison to the businesses regarding recall reporting functions. You are responsible for
To succeed in this role, you'll need a customer-first attitude and the following
- Accurate and on time tracking of open SCR Field Actions on a monthly basis
- Support Post Market Surveillance group with Competent Authority requests
- Collaborate with SRC business and Philips Q&R Market representatives to accurately track and document field corrective actions
- Work in SAP to run reports, update and review records
- Work with vendor(s) to provide accurate customer mailing tracking data that meets regulatory requirements
- Support external and internal audit of the reporting group when needed
- Perform other duties as assigned
- BS in technical or scientific discipline or equivalent education, experience, training
- Project Management skills are desired
- Minimum of 3 years of Quality and/or Regulatory experience in a medically regulated and technical environment
- An understanding of 21 CFR Part 820 (QSR), Part 7, 806, 810 (Recalls, Corrections and Removals)
- Demonstrated strong organization skills
- Proficiency using Philips tools (TrackWise, SAP)
- Proficiency in Microsoft Excel
- Must be able to work under pressure to meet regulatory reporting periods and company requirements.
- Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.
- Requires the proven ability to consistently meet and/or exceed goals.
- Must be capable of making commitments, setting priorities, and delivering results on time.
- Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa. In return, we offer you
Our benefits can be found here: https://www.careers.philips.com/na/en/total-rewards-at-philips .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 .
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