Quality Management System Specialist

We offer an interesting opportunity to join our Quality team, based in Bussolengo (VR) as Quality Management System Specialist , reporting to the Quality Management System Manager, on a full-time permanent contract.

As part of the Quality Team, he/she contributes to the implementation, maintenance, and continuous improvement of the Quality Management System, ensuring compliance with international standards and regulatory requirements such as ISO 13485, MDR 2017/745, and FDA 21 CFR Part 820.

The role focuses on maintaining the integrity and alignment of the QMS repository, managing the compliance of the training program, and supporting the organization in building a strong quality culture.

What will your contribution be?

• Support the QMS Manager in maintaining a compliant and effective Quality Management System across the organization
• Oversee the compliance and execution of the internal training process, in cooperation with all departments
• Ensure procedures and operative instructions remain adequate, up-to-date, and properly implemented within OF SRL
• Manage the full lifecycle of controlled documents
• Facilitate onboarding training for new hires and provide ongoing training support on quality topics
• Assist in preparation and follow-up of internal and third-party audits (e.g., Notified Bodies, Regulatory inspections)
• Monitor quality performance and escalate any deviations from company objectives
• Collect and analyze data for the Quality Management Review, supporting QMS manager in the preparation of QMR meetings.

What are we looking for?

• Preferred technical degree or master’s degree
• 1 year in similar positions, in multinational companies preferably operating in the Medical Device field
• Knowledge of ISO 13485, MDR 2017/745, FDA 21 CFR part 820 will be considered a plus
• Advanced knowledge of English
• Good knowledge of Microsoft office and with analysis and reporting tools

What soft skills will you improve?

• Ability to work precisely according to procedures, rules, and regulations
• Adherence to timelines and result result-oriented attitude
• Orderliness and attention to detail
• Analytical approach to resolve complex issues.
• Ability to work in team and autonomously.
• 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 permanent contract
• Salary package range: 30.000/35.000 euro*

*please note that this is a range; the complete salary package will be defined based on the seniority / skills of the person

Do you want to join us? Are you ready to make a difference?