QA Complaint Investigator 1
QA Complaint Investigator 1
The Business Unit (BU) Post Market Surveillance team assesses complaints and determines if these are reportable to the FDA and/or other World Wide Competent Authorities. The group also reports all correction and removal to the FDA and/or World Wide Competent Authorities. Evaluates, investigates, and resolves complaints. Completes initial assessment of reportability and escalates to manager to determine action, when necessary. Analyzes complaint data, gathers additional data as needed, and partners cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations, and resolves complaints.
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 representatives and Field Service Engineers (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 .
To succeed in this role, you should have the following skills and experience
- Bachelor's degree or equivalent work experience.
- 3+ years of related experience in a medical device or regulated industry.
- 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/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
- Masters degree or MBA
- FDA Class III experience
Why should you join Philips?
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