Supplier Quality Manager

Supplier Quality Manager

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. The Supplier Quality Manager is responsible for developing and managing the supplier quality program within an in vitro diagnostics manufacturing environment, ensuring suppliers meet regulatory requirements 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 related to supplier management.
• Lead risk assessments for suppliers and support overall supply chain risk management.
• Other duties as assigned.

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 7+ years of experience in Quality Assurance within IVD or medical device manufacturing.
• 3+ years of experience in supplier quality management or a related role.
• Proven experience leading internal and external audits.
• 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. Diasorin offers a competitive rewards package focused on overall well‑being, including health benefits, retirement and financial wellbeing, time‑off programs, wellbeing support and perks. An annual incentive program may also be available, depending on performance.

• 25% domestic travel may be required.
• 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 orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.