||Quality Analyst II
The incumbent is responsible for product investigations for applicable customer reported device related incidents. This position works with minimal supervision and requires a high degree of interaction with customers (internal and external).
• Review associated records and contact users and customers to collect information on product performance, functionality, etc.
• Conduct periodic follow-up to close complaints in a timely manner.
• Complete investigations, which may include execution or coordination of product returns and subsequent evaluations, review of manufacturing records and ensuring proper approvals are obtained as part of closure.
• Maintain patient confidentiality.
• Consulting with NxStage Clinical Staff as required.
• Full adherence to NxStage policies and procedures outlining complaint handling functions and activities.
• Full adherence to NxStage metrics for complaint handling
• Periodic reporting to Quality Engineering and management of complaint trends.
• Ensure that complaints are entered and closed-out based on NxStage SOP’s accurately.
• Other duties as assigned by the Postmarket management team.
||Education & Qualifications:
• A working knowledge of applicable FDA regulations governing complaints and Medical Device Reporting.
• 4+ years medical device complaint handling.
• Exceptional attention to detail and follow-through.
• Assumes responsibility for meeting commitments in a quality-oriented, results-focused manner.
• Excellent verbal communication.
• Ability to interface with multiple groups in the organization particularly Engineering.
• Excellent writing skills.
• Overall positive and optimistic attitude.
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