Junior Quality Complaints Engineer (Med Tech)

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

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).