Senior QA Technician (Medical Device - Hemodialysis Systems)

Job Title: Senior QA Technician (Medical Device – Hemodialysis Systems)

Company: ATR International (on behalf of our client, Diality Inc.)

Location: Irvine, CA (Onsite)

Employment Type: Contract (Hourly) — 12 Months — pay rate: $30/Hr

About the Role

ATR International is seeking a Senior QA Technician on behalf of our client, Diality Inc., a medical device company focused on developing solutions to improve lives impacted by kidney disease. Our client offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx System combines the flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to serve a broad range of prescriptions across any professional dialysis care setting.

The Senior QA Technician plays a critical role in ensuring 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 performs receiving inspections and oversees quality initiatives related to in-process and final product inspections, and supports non-conformance investigations and continuous improvement activities across production and quality functions.

Priority Skills for This Role

• Ability to create or modify CMM inspection programs — hands-on programming experience is a must, not just operating pre-built programs
• Experience with optical measurement systems, vision inspection systems, laser scanners, or portable CMM arms

Responsibilities

• Perform and document receiving and verification inspections of incoming materials, in-process assemblies, and finished medical devices for compliance with product specs and regulatory requirements
• Create, modify, and run CMM inspection programs; utilize precision measuring tools (calipers, micrometers, height gauges, vision systems, optical/laser measurement systems) and test equipment per 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
• Partner with Manufacturing Engineering and Quality Engineering teams to ensure ongoing product quality
• Maintain accurate records per Good Documentation Practices (GDP) and company quality procedures

Required Skills & Abilities

• Demonstrated ability to create/modify CMM inspection programs (programming, not just operation)
• Experience with optical measurement systems, vision inspection systems, laser scanners, or portable CMM arms
• Strong understanding of technical drawings, GD&T, and specifications
• Familiarity with QMS, ERP systems, and electronic documentation tools
• Excellent attention to detail and problem-solving skills; able to work independently and in a team environment
• 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 7 years of experience in QA/QC or quality inspection within medical device, pharmaceutical, or another regulated industry
• Strong knowledge of FDA Quality System Regulation, ISO 13485, and related standards

Travel

• Willingness to travel domestically as needed, primarily to visit vendors and attend select conferences

Physical Requirements
Primarily an office environment requiring frequent sitting, standing, and walking; daily use of a computer and other digital devices. May stand for extended periods during meetings or facility walks. Reasonable accommodations available per ADA.

ATR International is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, or any other protected characteristic.