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.
We offer an interesting opportunity to join our Quality Compliance team, based in Bussolengo (VR) as Junior Quality Complaints Engineer, reporting to the Quality Complaints Supervisor, on a full-time temporary contract.
As part of the Quality Team, you will be responsible for the effective management of post-market surveillance activities, with a primary focus on the intake, documentation, evaluation, and investigation of product complaints related to limb reconstruction medical devices.
You will This role ensures that all complaints are accurately recorded, assessed, and processed in compliance with applicable regulatory requirements, including MDR, FDA, and global vigilance regulations.
What will your contribution be?
Complaint Handling: record and manage complaints in the quality system, ensuring all information is complete and traceable.
Technical Evaluation: investigate complaints to identify device issues, possible failures, and root causes, working with relevant teams when needed.
Vigilance Reporting: assess whether events are reportable under regulations (e.g., EU MDR, FDA) and submit reports within required timelines.
Signal Detection: review complaint data to identify recurring issues/trends or potential risks.
Regulatory Compliance: ensure all complaint activities follow internal procedures and regulatory requirements, supporting audits.
What are we looking for?
Master’s degree in Biomedical Engineering or related field
1 year in similar positions in Medical Device companies
Advanced knowledge of English and Italian
Stron technical knowledge
Knowledge of 1 ISO13485, MDR 2017/745, FDA 21CFR part 820
Strong analytical mindset with a proactive approach
Problem-solving skills
Capability to work cross-functionally
Excellent organizational, problem-solving, and communication skills.
Proficiency in general Office applications (especially Microsoft Excel, Microsoft Word and Microsoft Power Point).
What soft skills will you improve?
Ability to work precisely according to procedures, rules, and regulations
Strong analytical mindset, attention to detail, and ability to manage multiple priorities.
Good interpersonal skills and ability to work in cross-functional teams.
Adherence to timelines and result result-oriented attitude
Orderliness and attention to detail
Accountability for the assigned tasks
What will you find?
Friendly, warm, and innovative atmosphere
Healthy, inspiring, and international and inclusive work environment
Training and development opportunities
Smart working model (two days per week)
Competitive reward packages
Social and company events
Wellbeing initiatives (welfare)
Canteen
Benefits (Pension Fund- Health Insurance)
What we offer?
Do you want to join us? Are you ready to make a difference?
We look forward to receiving your application.
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.
