Senior Product Experience Investigator in Lewisville, Texas at Orthofix

Why Orthofix?

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.

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:

• N/A

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 CONDITIONS

The 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.

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.

This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.

Since 1980, Orthofix has evolved and grown to become one of the leading medical device companies with a spine and orthopedics focus in the world. Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our products are distributed in 68 countries worldwide.

Our medical device company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, CA, and Verona, Italy. Our combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil.

Founded in Verona, Italy, and now headquartered in Lewisville, Texas, Orthofix is proud to be recognized as the 8th Largest Orthopedic Medical Device Company in the World by Medical Design & Outsourcing magazine. Orthofix is committed to improving patients’ lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organizations to meet the needs of their patients every day.