Supplier Quality Manager

• 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.

Job Scope

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.

Duties and Responsibilities

• 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 Manae 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.
• Manages Regular Supplier Review Board Meetings (global)
• Lead risk assessments for suppliers and support overall supply chain risk management.
• Other duties as assigned

Knowledge, Experience and Qualifications

• 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.

Training, Skills and Certifications

* 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.

Travel Requirements

• 25% Travel may be required
• 5% International travel may be required