Senior Product Experience Investigator

Orthofix • Lewisville, TX

6d

About The Position

Orthofix is seeking a Senior Product Experience Investigator who will be responsible for ensuring customer complaints are reviewed, evaluated, investigated, documented, and closed in a timely manner to ensure compliance with all applicable global regulatory requirements. The role also requires adherence to company quality system requirements and applicable standards and regulations. Orthofix is a global medical technology company with over 1,600 employees, focused on improving people's quality of life through innovative, cost-effective, and user-friendly medical technologies.

Requirements

• College degree or equivalent experience
• Excellent communication skills both oral and written.
• Detail-oriented; good analytical skills.
• Able to organize time and tasks efficiently.
• 3+ years of medical device experience.

Nice To Haves

• Prior regulatory or product complaint handling experience.
• Knowledge of Oracle, Business Objects, and MS Access a plus.
• Knowledge of company products is a plus.

Responsibilities

• Maintain customer complaint documentation including complaint details and product return information.
• Communicate directly with patients and physicians as required (e.g., telephone contact, written communication) during the investigation of customer complaints.
• Communicate with Orthofix personnel during the course of the investigation of customer complaints.
• Record complete and accurate findings regarding each complaint investigation, including the conclusion and any corrective action required.
• Determine the regulatory reporting requirements for each complaint and prepare the necessary reporting documentation for submission to regulatory agencies.
• Submit adverse events as required to the appropriate domestic and international regulatory agencies.
• Track, compile, and report on complaint metrics.
• Perform failure analysis for complaints, as necessary.
• Participate in continuous improvement activities as determined by goals and objectives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree