Philips Complaints Investigator in Pune, India
In this role, you have the opportunity to
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
• 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.
• Evaluate customer feedback and customer and internal data for possible complaint.
• Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint
• Communicate with call center reps and FSEs to gather more data on complaints as needed.
• Assist the Vigilance Reporting team in collecting the required data for initial assessment of reportability as well as any request of information from Competent Authorities and Notified Body.
• Support the screening of complaints for reported serious injury/deaths and the assignment to investigators within 2 business days.
• Investigate every complaint in all dimensions to gather information required for review and closure of complaint record according to the complaint handling procedure.
• Assess if the Risk assessment is covering the hazard in the complaint.
• Confirm complaint investigation and determine corrective action is needed as per applicable procedures (e.g. CAPA)
• Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed
• Complete all needed records in a timely and accurate manner.
• Review complaint records of other complaint investigators to warrant the quality of the complaint record.
• Analyze complaint data, gather additional data as needed, and partner cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations, and resolve complaints.
• Escalate to the CHU manager when necessary to determine action to drive timely and effective resolution of the complaint.
KEY PERFORMANCE INDICATORS:
No-major non-compliance in applicable process/records.
Non product feedback closure timeliness
Complaint record compliance completeness and timely closure
Complaint Closure Performance
To succeed in this role, you should have the following skills and experience
2- 3 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.
Good Verbal and written communication skills.
Analytical skills and focus on detail.
Teamwork in and outside Q&R.
Fluent in English (verbal and written).
Product Knowledge is preferred.
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 .
- Philips Jobs