Post Market Surveillance Consultant
12 months
Location: 1-2 weeks of training in Nashville, TN and then employees on site 5 days per week in Atlanta, GA or Nashville, TN
Description:
Key areas of responsibilities (KARS) for this role include:
o 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
o Evaluate customer feedback, service records, and other sources of customer and internal for possible complaint and reportable events.
o Initiate complaint in applicable Trackwise tool.
o Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint
o Communicate with customers, call center reps, Field Service Engineers to gather more data on records as needed
o Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed
o Complete all needed records in a timely and accurate manner
Location: 1-2 weeks of training in Nashville, TN and then employees on site 5 days per week in Atlanta, GA or Nashville, TN
We are looking for:
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people Philips brand touches each year.
Specific skill requirements for this role include:
o Bachelor’s degree or equivalence work experience
o 5+ years of related experience in a medical device or regulated industry.
o Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Part 803 and 820, ISO13485, ISO14971, and European Medical Device Directive (93/42/EEC).
Desired Qualifications:
o Product knowledge of Patient Monitors and external defibrillators
o Clinical or Technical experience in same