How you'll make a difference?Ensure customer complaints are reviewed, evaluated, investigated, documented, and closed in a timely manner to ensure compliance with all applicable global regulatory requirements. The Senior Product Experience Investigator must also ensure compliance with company quality system requirements as well as applicable standards and regulations.
What will your duties and responsibilities be?The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.
- 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.
What skills and experience will you need?The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.
Education/Certifications: - College degree or equivalent experience
Experience, Skills, Knowledge and/or Abilities:- 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.
What qualifications are preferred?The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.
Education/Certifications: Additional Experience, Skills, Knowledge and/or Abilities:- Prior regulatory or product complaint handling experience.
- Knowledge of Oracle, Business Objects, and MS Access a plus.
- Knowledge of company products is a plus.
PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONSThe physical requirements listed in this section include, but are not limited, to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.
- No additional physical requirements or essential functions for this position.
DISCLAIMER The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee's at-will employment status.
