Quality Engineer

Location: California

Quality Engineer

Published on:
Dec 18, 2025

Country:
United States

Location:

Cypress, California

Job Category:
Quality

Employment type:

Regular Full Time

Dia Sorin 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 have 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 Dia Sorin? Impactful Work:
When you join Dia Sorin, you become part of a team 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 Dia Sorin 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, Dia Sorin 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 Dia Sorin 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!

SUMMARY

Responsible for evaluating and optimizing manufacturing, QC, R&D and CAPA processes to improve product consistency and to increase productivity. Responsible for reviewing, performing and documenting validations for new and existing products. Supports all applicable regulations including but not limited to FDA, ISO, IVDD and IVDR requirements.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Review of design, manufacturing, purchasing and test documentation to ensure quality requirements are fulfilled.
• Review specifications, operation instructions, sheets, process procedures, test procedures, inspection and test analysis.
• Provide leadership in and employ advanced quality planning techniques (FMEA, Capability Studies, Measuring and Test Equipment Studies, Product Validation and Reliability Test).
• Assist in determining process/equipment capabilities.
• Assist in the development process flow diagrams and perform gap analyses on current controls versus required controls.
• Investigate the root cause of external and internal non-conforming products.
• Assist in corrective and preventive actions and verifications of effectiveness such as actions for customer complaints, internal audits and internal and external supplier non-conformance.
• Perform assessments for process-related risks.
• Assist in the development of inspection procedures and justified sample plans.
• Gather, analyze and report data reflecting status of product and process and provide recommendation to improve.
• Support new product development and growth. Represent quality on new product development teams with guidance from more senior quality engineers or management.
• Participate in improvement and lean projects.
• Perform internal audits.
• Responsible for performing assigned tasks in accordance with the company’s quality policies and procedures per the applicable quality management system regulations as defined in the Quality Manual.
• Responsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies. Violations of EHS regulations or policies will be handled in accordance with the…