Senior Product Experience Investigator

Orthofix•Lewisville, TX

About The Position

Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech. Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further.

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

Ensure customer complaints are reviewed, evaluated, investigated, documented, and closed in a timely manner to ensure compliance with all applicable global regulatory requirements.
Ensure compliance with company quality system requirements as well as applicable standards and regulations.
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. These reports include Medical Device Reports, Vigilance Reports, Canadian Problem Reports, etc.
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.