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 weve earned our reputation for excellence by developing innovative diagnostic assays and instruments that are 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.

Why Join Diasorin

• Impactful Work: When you join Diasorin you become part of a team thats 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 youre passionate about innovation diversity and making a positive impact on healthcare Diasorin is the place for you. Were 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 thats 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!

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

• Bachelors degree in Engineering Life Sciences or related field required.
• Masters 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

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 or protected veteran status and will not be discriminated against on the basis of disability.

In compliance with federal law all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process please contact the North America Talent Acquisition Team at or 1- to request an accommodation.

The above job description is intended to describe the general content identify the essential functions and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties responsibilities or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed written consent from the Diasorin Human Resources Department.