Job Description

The Quality team at Noah Medical is seeking a Manager, Complaints and Post-Market to ensure products, services, and processes meet the highest quality and regulatory standards. This role involves overseeing the complaint handling team, managing adverse event reporting, analyzing complaint metrics, and coordinating post-market surveillance activities.

Responsibilities

• Ensure compliance with quality and regulatory requirements
• Oversee complaint handling team activities
• Manage adverse event reporting
• Analyze complaint metrics and trends
• Schedule and complete post-market surveillance reports
• Coordinate with various teams for post-market surveillance information
• Initiate risk file updates
• Review customer inquiries and service reports for potential complaints
• Perform complaint case final reviews
• Manage complaint handling team and provide guidance
• Review, revise, and create SOPs and WIs
• Assist in audits

Requirements

• BS degree in a technical field
• 5+ years of complaint-handling experience in the medical device industry
• Ability to manage multiple priorities
• Working knowledge of the complaint handling process
• Strong working knowledge of US FDA 21 CFR 820.198, 803, and 806 requirements
• Basic working knowledge of OUS adverse event reporting and post-market surveillance requirements
• Working statistical knowledge
• Intermediate understanding of mechanical and software aspects of medical devices

Benefits

• No benefits