Junior Quality Complaints Engineer

Orthofix Holdings, Inc.; Verona, Bussolengo; Ibrido; EUR 30.000 - 35.000; Tempo pieno

Vantaggi offerti da questo lavoro

Smart working (2 days/wk)

Health insurance

Pension fund

Social events

Wellbeing initiatives

Descrizione del lavoro

Orthofix Holdings, Inc. in Bussolengo (VR) seeks a Junior Quality Complaints Engineer to manage post‑market surveillance, focusing on intake, documentation, evaluation, and investigation of complaints for limb reconstruction devices.

The role operates under the Quality Complaints Supervisor on a full‑time temporary contract, requiring a Master’s in Biomedical Engineering and 1 year in a medical device environment, with strong English/Italian and regulatory knowledge (MDR, FDA).

Competenze

• Master’s degree in Biomedical Engineering or related field.
• 1 year in similar positions in Medical Device companies.
• Advanced knowledge of English and Italian.
• Strong technical knowledge.
• Knowledge of 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 Microsoft Excel, Word and PowerPoint.

Mansioni

• 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 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.

Conoscenze

Analytical mindset

Problem solving

Cross-functional work

Strong communication

Formazione

Master’s degree in Biomedical Engineering

Strumenti

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Descrizione del lavoro

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. 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
• Strong technical knowledge
• Knowledge of 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‑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?

• This is a full‑time job
• The contract is a temporary contract
• Salary package range: 30.000/35.000 euro
• * The package will be evaluated based on the experience of the person

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.