ENGINEERING CHANGE COORDINATOR

Quanta System S.p.A.; Samarate; Hybrid; EUR 32,000 - 39,000; Full time

Job summary

Quanta System S.P.A. in Samarate, Lombardy, is seeking an Engineering Change Coordinator to join the Engineering Change Management team.

You will organize engineering change requests, assess impacts on schedules, costs, and resources, and ensure alignment with company standards and regulatory requirements. The role requires a Bachelor’s degree in engineering and hands-on experience in change management within regulated environments.

Qualifications

• Bachelor’s degree in Engineering or a related field.
• Experience in Change Management or similar roles within regulated environments.
• Knowledge of PLM systems (Windchill/Teamcenter) and QMS tools.
• Understanding of ISO 13485, Change Control processes, and ISO 14971.

Responsibilities

• Coordinate Engineering Change Requests, ensuring completeness, prioritization, and progress tracking.
• Assess the impact of changes on timelines, costs, resources, and involved functions.
• Monitor workflows, facilitate the resolution of pending actions, and support the timely completion of change activities.
• Ensure compliance with ISO 13485, MDR/FDA requirements, and internal procedures.
• Apply risk management principles, including ISO 14971 where applicable.
• Ensure proper version control of drawings, BOMs, and technical documentation.
• Maintain document traceability and update PLM and QMS systems.
• Support impact assessments, reporting activities, and data preparation for the Change Control Board.
• Collaborate with stakeholders across functions to promote alignment and address process-related issues.

Skills

Change Management

Education

Bachelor’s degree in Engineering

Tools

Windchill

Teamcenter

QMS tools

Job description

Company QUANTA SYSTEM S.P.A. Location Samarate, Italia Functional Area Technical Department Workplace type Hybrid Compensation Starting from 35.000,00 EUR per year

Company Description

WHO WE ARE

Quanta System is a 100% Italian company that offers on the global market innovative laser systems for Surgery, Aesthetics and Art Conservation since 1985.

Our main purpose is to increase our positive impact on the world through more than 30.000 installed lasers in 150 countries.

As a laser technology company, we innovate to improve life quality of people with one consistent belief: creating new perspectives for future generations by evolving with our most inner attitudes.

Cause there is always a way to make life better. And this way finds its answers in our daily actions.

Our company is constantly growing, in constant evolution not only in the search for innovation but above all for People and Talents who join our path.

We believe in sustainability, in responsibility; we are firm supporters of interpersonal relationships based on respect and mutual listening, among people who use creativity to seek out solutions that reflect and enhance each individual’s uniqueness and strengths.

Group Diversity, Equity & Inclusion Policy

Quanta System and the El.En. Group are committed to ensuring a positive, constructive, and dynamic work environment that supports the diversity of individuals and their talents, opinions, and perspectives, guaranteeing equal opportunities for all based on the principles of impartiality. Quanta System and the El.En. Group are dedicated to preventing any form of discrimination.

Position

We are looking for an Engineering Change Coordinator to join our Engineering Change Management team. In this role, you will coordinate product and process changes, ensuring activities progress smoothly, collaboration across teams is effective, and company standards and procedures are followed. What you will do:

• Coordinate Engineering Change Requests, ensuring completeness, prioritization, and progress tracking.
• Assess the impact of changes on timelines, costs, resources, and involved functions.
• Monitor workflows, facilitate the resolution of pending actions, and support the timely completion of change activities.
• Ensure compliance with ISO 13485, MDR/FDA requirements, and internal procedures.
• Apply risk management principles, including ISO 14971 where applicable.
• Ensure proper version control of drawings, BOMs, and technical documentation.
• Maintain document traceability and update PLM and QMS systems.
• Support impact assessments, reporting activities, and data preparation for the Change Control Board.
• Collaborate with stakeholders across functions to promote alignment and address process-related issues.

Requirements

• Bachelor’s degree in Engineering or a related field.
• Previous experience in Change Management or similar roles within regulated environments.
• Knowledge of PLM systems, such as Windchill or Teamcenter, and QMS tools.
• Understanding of ISO 13485, Change Control processes, and ISO 14971.
• Strong organizational skills, attention to detail, and effective communication abilities.
• Experience in the medical device industry is considered a plus.

Other information

What do we offer?

The minimum guaranteed gross annual salary is 35.000€.