Product Analyst

Our client a Major Medical Device Company is seeking someone to work directly with their clients. Must be Customer focused...

This is a Hybrid role

Product Analyst II

Job Purpose: Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers

Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.

Key Responsibilities:

• Leads efforts for complaint handling of customer responses including medical device incident reporting.

• Review customer feedback and requests and then assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.

• Apply clinical knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.

• Apply codes to events to facilitate product performance records. Review coding and investigations with engineering, laboratory, and other internal staff.

• Ensure that the correct documentation is in place at point of use in the Complaint.

• Prepare and present reports and status information to management as needed Quality Systems

Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all quality requirements. Qualifications: BA degree, plus 2-3 years' experience. Experience in Complaint handling. • Team player with excellent coordination, interpersonal and communication skills. • Self-directed requiring minimal supervision. Microsoft proficiency. Preferred Qualifications: • Previous Quality Assurance or complaint handling experiences preferred. • High level of proficiency with Microsoft (MS) Office applications (Excel, Word, Outlook).

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