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About the Role
The Quality Engineer II supports and maintains quality assurance activities within an In Vitro Diagnostics (IVD) manufacturing and development environment, ensuring compliance with regulatory requirements and supporting product lifecycle processes.
Responsibilities
- 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
- Perform other duties as assigned
Requirements
- 3-6 years of quality assurance or manufacturing experience in relevant industry required
- Individuals hired will be required to verify identity and eligibility to work
- May be subject to a background check and drug screening where permitted by law
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
Location
- Domestic travel may be required
- International travel may be required
Work Type
- Full-time
Experience Level
- Intermediate-level
- 3-6 years
Education Level
- Bachelor’s degree in Engineering, Life Sciences, or related field
- Advanced degree in a technical field with required relevant work experience
- Certification in a quality discipline, such as ASQ certified Quality Engineer (CQE), Quality Auditor (CQA), Six Sigma black belt, etc. preferred
About the Company
- Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide.
- For more than 50 years, Diasorin has combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.
- Diasorin continuously invests in research, technology, and people.
- Guided by values of operational excellence, customer focus, and teamwork, Diasorin empowers teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios.
- Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers.
- Diverse perspectives strengthen innovation and help deliver meaningful impact for patients and customers worldwide.
Equal Opportunity
- 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.
- Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process.