PURPOSE AND SCOPE:
The incumbent will provide support and direction to the execution ofthe complaint processes throughout the organization to monitor and analyzeproduct performance data from a variety of internal and external sources.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Ensuresprocesses and systems are effective to receive, review, and investigatecritical product complaints investigation. Reviews for closure various productcomplaints which include reportable complaints. Helps provide customer supportand serves as liaison between Quality Engineering, Postmarket Investigators,and Postmarket Clinical, and sales force regarding potential product problems.
Manage postmarket surveillance complaints intake staff
Manageinternational complaints investigations, escalation, and response
Prepareagendas, facilitates cross functional meetings to drive moderate to complexproduct complaint investigations and creates meeting minutes
Workwith Postmarket Surveillance and Quality Engineering personnel to ensurecomplaint records are accurate, complete, and follow good documentationpractices
Performqueries to provide complaint data and analysis on reported productproblems/complaints
Interfacewith distributors, sales force, international representatives, and in-housedepartments for complaint information
Reviewor prepare customer communication (response letters, acknowledgement letters)as appropriate
Drivecontinuous quality improvement
Createor update QMS documents
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA/BSin a life sciences field and 4 years applicable experience; or 8 yearsexperience working directly with customers in a complaint handling capacity.
EXPERIENCE AND REQUIRED SKILLS:
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