Supplier Quality 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.

• Impactful Work:
  Your contributions will directly impact patient care and make a meaningful difference in the world.
• Global Reach & Innovation:
  Collaborate with colleagues from all over the world and contribute to global healthcare solutions at the forefront of the diagnostic industry.

Diverse and Inclusive Culture:
We believe in the strength of diversity and offer a supportive, collaborative environment where everyone can thrive.

Join our team if you are passionate about innovation, diversity, and making a positive impact on healthcare. We’re looking for talented individuals ready to embrace new challenges and drive healthcare solutions forward.

The Supplier Quality Manager is responsible for developing and managing the supplier quality program within an in vitro diagnostics (IVD) manufacturing environment. This role ensures that suppliers of raw materials, components, and services meet applicable regulatory requirements (FDA 21 CFR Part 820, ISO 13485, IVDR) and company quality standards. The Supplier Quality Manager partners with Procurement, Manufacturing, R&D, and Regulatory Affairs to drive supplier qualification, audits, continuous improvement, and compliance.

• Develop, implement, and maintain the supplier quality management program.
• Manage and conduct supplier audits in accordance with FDA, ISO 13485, MDSAP, and IVDR requirements.
• Qualify and approve new suppliers, materials, and services for use in IVD manufacturing.
• Manage supplier corrective actions (SCARs) and ensure timely resolution of quality issues.
• Assign and manage Supplier Quality Scorecard assessments.
• Collaborate with Procurement and R&D during supplier selection and qualification.
• Review and approve supplier change notifications.
• Monitor supplier performance metrics and drive continuous improvement initiatives.
• Ensure supplier compliance with product, regulatory, and contractual requirements.
• Act as SME during regulatory inspections for supplier management topics.
• Manage regular Supplier Review Board meetings (global).
• Lead risk assessments for suppliers and support overall supply chain risk management.
• Other duties as assigned.

• Bachelor’s degree in Engineering, Life Sciences, or related field required.
• Master’s degree preferred.
• 7+ years of experience in Quality Assurance within IVD or medical device manufacturing.
• 3+ years of experience in supplier quality management or related role.
• Proven experience leading audits (internal and external).
• Experience with FDA 21 CFR 820, ISO 13485, IVDR, and ISO 14971 risk management.

• Strong knowledge of supplier quality principles, auditing, and risk management.
• Thorough knowledge of FDA regulations and cGMP guidelines, ISO 13485, IVDR.
• Excellent problem‑solving and root‑cause analysis skills.
• Highly organized with proven time‑management skills.
• Strong communication and negotiation skills with suppliers and internal teams.
• Proficiency with electronic Quality Management Systems (eQMS).
• ASQ certifications (CQA, CQE, or equivalent) preferred.

The hiring range for this position is $120,000–$140,000 annual base salary. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well‑being, including a comprehensive plan of health benefits, retirement and financial wellbeing, time‑off programs, wellbeing support and perks. You may also be eligible to participate in an annual incentive program.

• Up to 25% domestic travel may be required.
• Up to 5% international travel may be required.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual…