Job TitleComplaint Investigator
The Complaint Investigator evaluates, investigates, and resolves complaints, initiates CAPAs, analyzes complaint data, gathers additional data as needed, and provides feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations.
- 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 incoming data and determine if it is sufficient to understand the nature of the complaint
- Determine regulatory reportability of complaints received
- 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
We welcome you to join Philips HealthTech as a Complaint Investigator for our cutting edge Ultrasound business. The Quality and Regulatory team enables Ultrasound to bring meaningful innovation to our customers by partnering with and guiding the business to achieve world class quality and full regulatory compliance, while creating a great workplace for our people to realize their career aspirations.
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 impact regulatory compliance worldwide and directly improve the customer and patient experience.
We are looking for
- 5-7 years’ experience
- Bachelor’s degree in biomedical sciences, or other technical degrees
- Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and ISO9001, and FDA QSR. Medical Device and or other regulated industry (Pharma, IVD,) preferred.
- An organized, analytical thinker with exceptional attention to detail
- An excellent communicator, both written and verbal for coordinating with colleagues and regulatory authorities worldwide
- Experience in TrackWise an asset
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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.
In case of difficulties with your job application please send an email to [email protected]
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