Post Market QA, Audit and Vigilance Manager

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 have earned our reputation for excellence by developing innovative diagnostic assays and instruments 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.”

• Impactful Work:
  When you join Diasorin, you become part of a team 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.

Are you ready to be part of a dynamic team that’s shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

This role serves as the lead for Post Market Quality Assurance and Audit activities for Diasorin Inc., including product Vigilance/Recalls, Post‑market Review and Internal/External Audit.

• Participate in the Quality Assurance management team to set priorities and policy for the team to ensure support of the organization.
• Administer and maintain the Vigilance and Recall quality assurance process at Diasorin Inc.
• Monitor the suitability and effectiveness of the Quality System and ensure compliance with current U.S. and international regulations, ISO 13485 / ISO 9001 standards and IVDR through Internal Audit and other activities. Responsible for Norms management within Diasorin Inc. and updates related to evolving regulatory requirements.
• Lead external audits by regulatory authorities, notified bodies, customers, etc. Serve as an audit host and organize the audit process.
• Support post‑market activities through review of complaint files and complaint investigations for compliance as well as product‑specific post‑market reviews.
• Report on Quality Assurance KPI and outcomes in meetings from team level to corporate level, and responsible for weekly surveillance reporting at corporate level.
• This team supports Change Management with Quality Systems team and provides backup support to Document systems / Batch release.
• Direct continuous improvement of our processes to meet the evolving expectations of customers, business partners and regulators.
• Provide leadership to the team, ensuring clear and aligned objectives, supporting employee development, and encouraging collaboration across the organization.

• May act as Person Responsible for Regulatory Compliance (PRRC) and as designee for the following as detailed in Article 15 of the EU IVDR 2017/746:
  • Ensure that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
  • Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up‑to‑date;
  • Ensure that the post‑market surveillance obligations are complied with in accordance with Article 10(9);
  • Ensure that the reporting obligations referred to in…