QA Product Quality Specialist
Pubblicato il 18-08-2026 - Diasorin in Saluggia
Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.
Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."
Why Join Diasorin?
**Impactful Work**: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.
**Global Reach & Innovation**: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
**Diverse and Inclusive Culture**: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.
**Join Our Team**: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.
Job Scope
The QA Product Quality Specialist supports the QA Product Quality Manager in all the activities related to Investigation, nonconformities (NC),
CAPA and Post Market Surveillance processes and ensures that all the activities are performed according to internal procedures and in compliance with regulation requirements.
In addition, through the Quality Assurance function ensures that:
the industrial activities are fit for purpose, consistent and meet all internal and external requirements
the Quality System is compliant with the regulatory and quality requirements
Key **Responsibilities**:
Support the correct process of NCs, CAPAs and Investigations handling and verify that it complies with the procedures
Support the collection of Post-Market Surveillance (PMS) data and the management of the relevant PMS documentation
Monitor adherence to the defined timelines
Escalate to the line manager critical issues arising from NC, CAPA and Investigation management
Support industrial departments coordinating the non-conformity/Out of Specification management processes
Collaborate with the technical teams in the definition of the correct risk assessment on the product/processes
Verify, approve and close NCs, CAPAs and investigations records
Propose, track and monitor the quality KPIs and define actions for continuous improvement
Collaborate during internal and external audits for the NCs, CAPAs, Investigations and PMS topics discussion
Collect final data from NCs, CAPA and Investigations for the preparation of annual data analysis reports
Provide trainings and spread the knowledge of the correct NCs-CAPAs management and Investigation and Root Cause Analysis tools
Collaborate with the technical teams in the definition of the correct risk assessment on the product/processes
Support in evaluating the criticality of a non-conformance, defining the correct actions to be implemented and preventing recurrence of the issues
Draft and review standard operative procedures and to manage the Change Plans to modify them
Perform training personnel about the requirements of QMS and cGMP
Draft and review of standard operative procedures
Verify that procedures are properly established and applied to prevent non-conformity
Evaluate the impact of the proposed Changes on its own field of competence
Collaborate during audits conducted by external bodies
Education, Experience, and Qualifications
Degree in scientific disciplines or degree in biomedical engineering.
At least two years' experience in similar or equivalent positions in chemical/pharmaceutical or medical device companies, or experience in the production/quality control of medical devices.
Knowledge of ISO 13485, ISO9001, FDA code, EU IVD regulation 2017/746 (IVDR).
Use of Office pack (Excel, PowerPoint, Word).
Risk management and related tools. Knowledge of investigation and Root Cause Analysis tools.
Use of Office pack (Excel, PowerPoint, Word).
Risk management and related tools.
Strong verbal and written communication skills.
Solid problem solving and analytical skills.
Solid interpersonal skills, including ability to negotiate and influence without authority.
Ability to work in a team and promote teamwork, with respect for others.
Strong communication and interpersonal skills with ability to work well in a high-pressure environment.
Ability to manage complex projects a