Supplier Quality Manager

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. 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!

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 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

• 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. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off…