Senior Quality Assurance Technician at DIALITY INC – Irvine, California

Company & Job Overview:

Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.

The Quality Assurance (QA) Technician plays a critical role in ensuring that medical devices are manufactured in compliance with internal quality standards and applicable regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485). This role involves performing receiving, inspections and overseeing quality initiatives related to in-process and final product inspections. The QA Technician will also support investigations of non-conformances and continuous improvement activities across the production and quality functions.

Responsibilities:

• Perform receiving and verification activities. Perform and document inspections of incoming materials, in-process assemblies, and finished medical devices to ensure compliance with product specifications and regulatory requirements.
• Utilize precision measuring tools (e.g., calipers, micrometers, height gauges, vision systems) and test equipment in accordance with approved procedures.
• Support calibration, equipment qualification, and environmental monitoring programs.
• Review and approve Device History Records (DHRs) and batch documentation for completeness and compliance.
• Identify and report non-conformances; initiate and support Non-Conformance Reports (NCMRs)
• Participate in internal audits
• Work closely with Manufacturing Engineering and Quality Engineering teams to ensure ongoing product quality.
• Maintain accurate records in accordance with Good Documentation Practices (GDP) and company quality procedures.

Required Skills & Abilities

• Strong understanding of technical drawings, GD&T, and specifications.
• Proficiency in the use of inspection tools and equipment.
• Familiarity with quality management systems (QMS), ERP systems, and electronic documentation tools.
• Excellent attention to detail, problem-solving skills, and ability to work independently and in a team environment.
• Proficient in the use of measurement tools (calipers, micrometers, etc.) and quality inspection techniques. Proficient in the use of probe-based CMM a plus.
• Proficient in Microsoft Office Suite (Word, Excel, Outlook).
• Effective verbal and written communication skills.

Education & Experience:

• Associate’s or bachelor’s degree in a technical field preferred.
• Minimum of 7 years of experience in QA/QC and/or quality inspection within the medical device, pharmaceutical, or other regulated industry.
• Strong knowledge of FDA Quality System Regulation, ISO 13485, and other relevant standards.

Physical Requirements

• Primarily works in a manufacturing or laboratory environment.
• May be required to stand or sit for extended periods and lift up to 25 lbs.
• Use of personal protective equipment (PPE) may be required depending on work area.

Travel:

• Occasional travel required.