In this role, you have the opportunity to
Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.
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) – 2017/745
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
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.