Associate Quality Engineer

Diasorin; Austin (TX); On-site; USD 60,000 - 90,000; Full time

Job summary

Diasorin, a global leader in immunodiagnostic and molecular diagnostic solutions, seeks an Associate Quality Engineer to join our Austin, TX team. The role supports the Quality Management System to ensure regulatory compliance and internal quality standards for manufacturing, RUO and IVD products.

You will work on nonconformance management, CAPA, risk management, validation activities, audits, and cross-functional collaboration to improve product quality and patient outcomes.

Qualifications

• Bachelor's Degree in Life Sciences or Engineering (or equivalent) is required.
• 1+ years related experience in IVD, medical, pharmaceutical, or related industry.
• Proven experience in Process, Product, and/or Method Validation is required.
• ASQ Certified Quality Engineer preferred.

Responsibilities

• Support documentation updates and quality records maintenance.
• Assist with change control, deviations, and nonconformance processing.
• Support equipment qualification and validation activities under supervision.
• Participate in data collection, trending, and metric reporting.
• Assist with internal audit preparation activities.
• Support complaint investigations and basic CAPA activities as assigned.
• Learn regulatory requirements applicable to IVD products.
• Provide general quality support to manufacturing and engineering teams.
• Support and participate in other QA related activities as required.
• Other duties as assigned

Skills

Quality Principles

Documentation

Attention to Detail

Analytical Mindset

Communication

Cross-functional teamwork

MS Office

Data entry systems

Education

Bachelor's Degree in Life Sciences or Engineering

ASQ Certified Quality Engineer preferred

Tools

Microsoft Office

Job description

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.

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.

Why Join Diasorin

• 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 Associate Quality Engineer supports the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements and internal quality standards for further manufacture, Research Use Only (RUO) and in vitro diagnostic (IVD) products. This role assists with quality system processes including nonconformance management, CAPA, risk management, and production quality oversight.

Responsibilities And Duties

• Support documentation updates and quality records maintenan
• Assist with change control, deviations, and nonconformance processing
• Support equipment qualification and validation activities under supervision
• Participate in data collection, trending, and metric reporting
• Assist with internal audit preparation activities
• Support complaint investigations and basic CAPA activities as assigne
• Learn regulatory requirements applicable to IVD product
• Provide general quality support to manufacturing and engineering teams
• Support and participate in other QA related activities as required
• Other duties as assigned

Education, Experience And Qualifications

• Bachelor's Degree and/or equivalent experience in a Life Sciences discipline (Biochemistry, Chemistry, Microbiology, etc.) or Engineering discipline (Mechanical, Electrical or Industrial Engineering).
• 1+ Years related experience in IVD, medical, pharmaceutical, or other related industry.
• Proven experience in Process, Product, and/or Method Validation is required.

Licenses and Certifications

• ASQ Certified Quality Engineer preferred.

Training And Skills

• Foundational understanding of quality principles and regulated environments
• Strong organizational and documentation skills
• High attention to detail and accuracy
• Analytical mindset with willingness to learn root cause methodologies
• Effective written and verbal communication skills
• Ability to work collaboratively in cross-functional teams
• Proficient in Microsoft Office and data entry systems

What We Offer

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 programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.

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 [e-mail].

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 [e-mail] for verification.

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