Senior Quality Engineer

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Senior Quality Engineer

Published on:
Oct 15, 2025

Country:
United States

Location:

Cypress, California

Job Category:
Quality

Employment type:

Regular Full Time

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, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world. Diasorin’s 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 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!

Job Scope

The Sr QA Engineer will be responsible for tasks related to on‑going quality programs; quality system development and implementation, validations and process development, design change, corrective and preventive action, change control, and quality audits to ensure that assigned Luminex products meet established specifications, design criteria and control, quality and regulatory standards and customer requirements. The Senior Quality Engineer will trend quality data, evaluate risk and make proposals for continuous improvement.

The Senior Quality Assurance Engineer is a leader and a mentor.

Job Tasks and Responsibilities

• Provide inputs to process validation activities and process risk decisions (PVMP/PFMEA)
• Review, consult, and approve validations and equipment/instrument qualifications (IQ, OQ, PQ, Process, off‑the‑shelf software, etc.)
• Review, consult, and approve design change activities
• Evaluate deviations, non‑conformances, out of specifications, customer complaints and process change controls for completeness and impact on product quality
• Review, consult, and approve risk analysis
• Conduct or serve as a lead/coordinator of investigations for corrective and preventive action (CAPA)
• Prepare and trend data/materials for meetings and present
• Participate in audits and inspections
• Participate in various review boards as required, example Supplier Review board, Material Review board
• Collaborate with operations on the implementation of process controls and improvements
• Write and/or implement changes to controlled documents as needed.
• Investigate and collaborate with other departments to resolve quality issues
• Provide day‑to‑day guidance and training to other QA personnel, as required.
• Support Quality system training and participates in the development of training programs regarding all aspects of producing quality products.
• Provide day‑to‑day support for manufacturing to resolve any quality issues.
• Leader in Quality system continuous improvement activities
• Mentors personnel to continuously enhance the company’s quality culture
• Support and…