Quality Engineer II

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry's broadest specialty diagnostic portfolios.

When you join Diasorin, you are not just filling a role. You are helping build what comes next.

• Build What Matters
  Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.
• Innovate with Agility at a Global Scale
  Work in an entrepreneurial environment that enables speed, collaboration, and global impact.
• Grow in a People-Centered Culture
  Thrive in a culture that values accountability, inclusion, and continuous development.

Job Scope

The Quality Engineer II is responsible for supporting and maintaining quality assurance activities within an In Vitro Diagnostics (IVD) manufacturing and development environment. This role ensures compliance with applicable regulatory requirements, including U.S. Food and Drug Administration regulations (21 CFR Part 820), ISO 13485, and other global standards governing medical devices and diagnostic products.
The Quality Engineer II applies intermediate-level technical knowledge to support product lifecycle processes, including design controls, risk management, process validation, and production quality. This role partners cross-functionally with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to ensure product quality and continuous improvement.

Duties & Responsibilites

• Execute quality engineering tasks for manufacturing support
• Write and review protocols (IQ, OQ, PQ, TMV)
• Support design transfer and risk management activities
• Lead problem-solving using root cause methodologies
• Participate in internal audits
• Cross train and perform other interdepartmental responsibilities as required.
• Other duties as assigned

Education, Experience & Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field
• Advanced degree in a technical field with required relevant work experience
• 3-6 years of quality assurance or manufacturing experience in relevant industry required
• Certification in a quality discipline, such as ASQ certified Quality Engineer (CQE), Quality Auditor (CQA), Six Sigma black belt, etc.preferred

Training & Skills

• Working knowledge of quality systems in IVD
• Experience in process validation, test method validation
• Familiarity with ISO 13485 and FDA QSR
• Strong analytical and documentation skills

Travel

• 10% Domestic travel may be required
• 5% International travel

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.

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.

This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.

Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact View email address on click.appcast.io.

Recruitment Fraud Notice

Diasorin never requests payment, financial information, or personal banking details from candidates at any stage of the recruitment process. Official communications from Diasorin recruiters will only come from a verified @diasorin.com email address. If you have questions about the legitimacy of a recruitment communication, please contact View email address on click.appcast.io for verification.

Unauthorized third-party recruiting agencies may not submit candidates for this position without prior written authorization from the Diasorin Human Resources Department.