In this role, you have the opportunity to
Manage and lead the complaint handling team and 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 investigation.
You are responsible for
Manage the Pune complaint Handling Team.
Manage complaint handling, vigilance reporting, PMS activities and improvement projects
Be the point of contact for global PMS management in Hamburg and for local Q&R management in Pune
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 complain
Complete all needed records in a timely and accurate manner
Act as a Safety Manager for Pune legacy and Microdose products
You are a part of
HIC Pune is a product innovation center for multiple businesses with presence of R&D, Marketing, Customer Service, Procurement, Quality and Manufacturing functions. The center is focused on developing smart and reliable X-ray imaging based Diagnostics and Treatment products with enhanced patient safety to meet the unmet needs of a wide range of global hospital customer base.
To succeed in this role, you should have the following skills and experience
BE/B.Tech or Masters degree with over 10 years of experience
5-6 years of experience in similar kind of role from medical device industry or regulated industry.
Understanding of Complaint investigation process, global medical device regulations requirements and standards such as 21 CFR Parts 803, 806, and 820 & ISO13485. Knowledge on ISO 14971 is preferable.
Experience in Post market surveillance
FSE background is preferable
Good Verbal and written communication skills.
Team Management skill
Analytical skills and focus on detail.
Teamwork in and outside Q&R.
Fluent in English (verbal and written).
Product Knowledge is preferred, Radiology and Fluoroscopy background preferable DXR product knowledge
In return, we offer you
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
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. Learn more by watching this video .
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 .