Manager, Complaints and Post-Market

Position Overview

• Location Type: Remote
• Employment Type: Full-time
• Salary: Not specified

About Noah Medical: Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.

About The Team

The Quality team is an integral part of ensuring products, services, and processes are of the highest quality and meet customer and regulatory requirements. We are a team of detail-oriented professionals who take pride in meticulously assessing processes, products, and services to identify and rectify issues, ensuring the utmost quality and customer satisfaction. If you share our passion for maintaining the highest standards of quality and are dedicated to making a positive impact, we invite you to consider joining our Quality Assurance Team. Together, we can continue to elevate our organization's quality standards and provide unparalleled value to our customers and stakeholders.

Manager, Complaints and Post-Market - A Day In The Life

• Perform a wide variety of activities to ensure compliance with applicable quality and regulatory requirements.
• Oversee day-to-day activities of the complaint handling team, ensuring complaints are handled promptly and accurately.
• Work closely with Product Quality Engineering team to ensure that investigations and complaints are completed and closed out in a timely manner.
• Review complaint files to ensure all complaint elements have been addressed and properly documented within the complaint file.
• Manage adverse event reporting activities including decision rationale and reporting documentation.
• Submit adverse event reports to regulatory authorities.
• Manage complaint metrics and analytics including trending and measure against statistical trend limits.
• Schedule post market surveillance reviews and complete post market surveillance reports based on applicable regulatory requirements.
• Coordinate with clinical, marketing, sales, regulatory, and R&D to obtain their respective post market surveillance information based on regulatory requirements.
• Initiate risk file updates based on post market data such as complaint rates and new hazards.
• Review customer inquiries and service reports for potential complaints.
• Identify and escalate complaints for potential adverse event reporting decisions.
• Perform complaint case final reviews for closure.
• Manage complaint handling team activities and provide guidance as needed.
• Review, revise and create SOPs (Standard Operating Procedures) and/or WIs (Work Instructions) related to complaint handling.

Requirements

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Responsibilities

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Application Instructions

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