Primary responsibilities include: Conducting and documenting product complaint investigation in compliance with the requirements of FDA and ISO 13485. Responsible for receiving product complaint devices and evaluating the returned devices to determine the root cause and corrective action.
Monitors and compiles customer complaints data for product quality trends and need for issue escalation.
Provides inter-department feedback for investigation and to resolve product quality issues. Partners with R&D, Marketing, Medical, and Operations as applicable to help determine root cause and identify any necessary corrective action.
Investigates customer complaints for product quality issues and concerns.
Initiates product failure investigation and establishes and leads a failure investigation team.
Receives product complaint devices following decontamination and documents into the ETQ complaint handling software system.
Researches device history records associated with the manufacture of the product.
Photographs and dispositions product complaint devices (to lab for material testing or to complaint department for investigation)
Evaluates returned complaint devices and/or samples from inventory for visual, dimensional and or functional testing.
Performs a health hazard evaluation. Prepares failure investigation summary report.
Partners on investigations with technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of corrective and preventative action, and subsequent closure of investigations.
Leads effort to identify corrective and preventative actions based on root cause failure investigations
Assesses and analyzes customer complaints for potential regulatory reporting, based on product specific criteria.
Performs daily review of complaints and notifies original equipment manufacturers vendors as appropriate.
Performs assessment of adverse events.
Make recommendations and requests to affiliates, suppliers, sales consultants, customers and others to support complaint investigations.
Write investigational summaries and reports.
Participate in product issue meetings, including discussions of Corrective and Preventive actions arising from the evaluation of complaints.
B.S /BA in Engineering or related field /or equivalent experience with medical device manufacturer
3-5 years experience in medical device manufacturing company
Strong working knowledge of the QSR requirements related to product complaint handling and MDR, MDV reporting.
Excellent written and verbal communication skills with personnel on all levels including medical professionals and regulatory agencies.
Positive, energetic customer focus
Strong computer skills, including MS Office products
Experience with root cause analysis tools and medical device investigation
Must be able to follow detailed procedures