Engineering Change Coordinator - Hybrid, Medical Devices

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

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.