Engineer - Complaints at Orthofix – Lewisville, Idaho

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?

In this role, you have the opportunity to evaluate, investigate, and resolve complaints while also analyzing complaint data and gathering additional information as needed. You will manage the complaint investigation process end-to-end. You will work with other teams in a collaborative environment to complete the end-to-end complaints process in a highly regulated environment.

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.

• Evaluate, investigate, track and complete complaints through effective and established complaint handling process.

• Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.

• Collaborate with Engineering, Customer Support, Field personnel, and other appropriate groups for adequate initial evaluation of complaints.

• Participate and collaborate objectively with productive conclusions in the Complaint Handling Unit meetings.

• Coordinate with the reportable complaint investigators in providing any missing information for root cause activities.

• Collaborate with Complaint Handling Unit for reportable complaints as well as CAPA Review Board for Correction and Removal process.

• Assist in trending of complaints and collaborate with the appropriate groups to ensure that the data gets pushed to the appropriate departments for actions.

• Support reviews and audits assigned.

• Identify and drive process related improvements related to compliance and efficiency gains

• Work with the Complaint Handling Supervisor for any other projects assigned.

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:

• BS in engineering discipline or equivalent education, experience, training.

Experience, Skills, Knowledge and/or Abilities:

• 3+ years of experience in a medically regulated and technical environment. Experience with electrical components and/or medical device software is a plus.

• Demonstrated strong results orientation.

• Proficiency using statistical tools, office tools, and various other computer software applications.

• Must be able to work under pressure to meet regulatory reporting time frames and company requirements.

• Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.

• Requires the proven ability to consistently meet and/or exceed goals. Must be capable of making commitments, setting priorities, and delivering results on time.

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:

• N/A

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.