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Senior Quality Assurance Scientist Complaint Handling 9/16/2017

Beckman Coulter, Inc. Miami, FL

Company
Beckman Coulter, Inc.
Job Classification
Full Time
Company Ref #
374276
Location
Miami, FL
Experience
Entry Level (0 - 2 years)
Job Type
Regular
AJE Ref #
579542774

JOB DESCRIPTION

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The Senior Quality Assurance Scientist will participate in complaint handling activities for the purpose of ensuring compliance with US and international regulatory compliance and medical device reporting requirements, as well as improving the customer experience. These activities will include receiving, documenting, evaluating, and managing all complaints and other Customer Feedback (CF).

Responsibilities:
Receive and process complaints escalated from internal and external customers related to products manufactured and or distributed and serviced by the company in a manner consistent with all laws and regulations for medical devices.
Apply departmental procedures to the evaluation of complaint information for acceptable content and supporting data.
Generate and analyze customer feedback (CF) data to improve product reliability and performance for our customers.
Assess complaint information for determination of adverse event reporting and/or vigilance reporting.
Contact customer with findings of CF/complaint investigation as needed, and document outcome of the customer call or write a customer letter.
Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans.
Independently and collaboratively evaluate information, reports, and data and provide recommendations for process improvements.
Verify accuracy and completeness of pertinent records and documentation.
Possess understanding of risk management concepts and is capable of assessing product risks across unit of work.
Identify critical product issues and escalate through the quality system for Field Action, Corrective and Preventive Action (CAPA), Supplier Corrective Action, and/or Stop Shipment activities.
Provide input to project teams on project specific processes and deliverables. Ensure completion of key deliverables.
Perform queries as necessary to respond to regulatory requests/inquiries.
Upon request, performs specific data queries, prepares complaint reports, and communicates the results.
Other duties and projects as may be assigned.