In this role, you have the opportunity to
Evaluate, investigate, and resolve complaints while also analyzing complaint data and gathering additional information as needed. You will manage the complaint investigation process end-to-end. You will work with other teams in a collaborative environment to complete the end-to-end complaints process in a highly regulated environment.
You are responsible for
- Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint handling process globally.
- Evaluate customer feedback, service records, and other sources of customer and internal for possible complaint.
- Initiate complaint in process and applicable tool.
- Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint.
- Communicate with customers, call center reps and FSEs to gather more data on complaints as needed.
- Confirm complaint condition and determine corrective action (including CAPA as needed).
- Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed.
- Assess if the Risk assessment is covering the hazard in the complaint.
- Complete all needed records in a timely and accurate manner.
- Support Post Market Surveillance (PMS) activities required for compliance with the new European Medical Device Regulation (EU MDR) – 2017/74
You are a part of
An organization that believes-what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you will find when you work at Philips, that your professional and personal lives often intersect in unexpected and fulfilling ways. It is our mission to improve people’s lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.
To succeed in this role, you should have the following skills and experience
- Bachelor degree or equivalent work experience
- Working Knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98282), Japanese MHLW Ordinance 169, and ISO 9001
- 3+ years of related experience in a medical device or regulated industry
- Local post market surveillance regulation (21CFR, MDD93/42/EEC, other applicable market regulations), ISO14971 Risk Management
- Previous experience in Medical device and or applicable Consumer product
- Experience in maintenance and or troubleshooting of technical systems
In return, we offer you
At Philips, we strive to make the world healthier and more sustainable through innovation, and our goal is to improve the lives of 3 billion people a year by 2025. This position offers the opportunity to influence regulatory compliance worldwide and directly improve the customer and patient experience. We offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
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 improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the 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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