System Development & Integration – Global Immuno Quality Eng - Saluggia, Italy - ITA 2023-016

Job Title

System Development & Integration – Global Immuno Quality Eng

Job Facts

Organizational Area
Italy and UK Branch
Country / State
Place of work
Home/Office based
Office based

Professional Family: 

  • R&D - SD&I
Reporting To

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Job ID
ITA 2023-016

Job Scope

Your Mission

To act as the Team’s primary interface to the Quality and Regulatory departments within the Company, for all what relates to the documental side of development and improvement of the Immuno devices, with particular reference to complex and multi-faceted systems and projects.

Main Responsibilities

Your Contributions
  • Build and keep updated development documents with primary quality relevance, such as Risk Management Plan, Risk Analysis, Gap Analysis, Impact Analysis, for complex projects involving a broad spectrum of competences
  • Manage Change Plans and Change Requests within the QMS, in particular:
    o Issue of the Change Plan / Change Request
    o Preparation of the related deliverable and task plan
    o Negotiation and fine tuning of the CP/CR and related deliverables
    o Monitoring of advancement for tasks and related formal approvals
    · Supervision to regulatory requirements related to or impacting on systems for specific markets
    · Guidance for submissions and consultations to notified bodies and agencies (e.g. USA FDA, China NMPA)
    · Preparation of answers to enquiries from notified bodies and agencies
    · Issue and update of procedures relevant for the Team
    · Issue and update end certain documents for end users, where the quality / regulatory impact is relevant
    · Direct cooperation with the technical teams for the preparation of the mentioned deliverables
    · Direct cooperation with QA/RA teams

Qualifications Experience Personal Strengths Mobility

Bachelor’s Degree

3-5 years’ experience in an equivalent role or as a QA/RA specialist
· 1-2 years’ experience in a technical field is a plus
· Previous experience in IVD (In Vitro Diagnostics) and/or highly regulated FDA environments and biotechnology industry experience is highly appreciated

Technical Competencies

· Knowledge of GMP (Good Manufacturing Practice) is appreciated
· Experience with working under ISO 13485
· Used to discuss technical topics
· Seasoned experience using Microsoft Office package


· Effective ability to analyze and synthesize
· Interdisciplinary thought
· Clear and concise writing skills
· Well organized, ability to work well independently as well as part of a team
· High commitment and willingness to learn
· Positive, proactive and open-minded attitude
· Focus on results

Fluent spoken and written Italian and English
Travel Availability
Travels may be required from time to time
Relocation Availability
Training Required

Induction program once hired


We Offer You

As per Company Policy