Why Orthofix?
We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system.
Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning!
Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients.
At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by : Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun!
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?
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?
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?
Education / Certifications :
N / A
Additional Experience, Skills, Knowledge and / or Abilities :
N / A
PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS
No additional physical requirements or essential functions for this position.
DISCLAIMER
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