QA Specialist

Location: Huntington Beach, CA
Compensation: $$90,000-$110,000

About the Role

At SprintRay, we are in a super-charged growth mode and are constantly looking for ways to maintain the quality of our products and processes while growing at a phenomenal pace. To help maintain our quality standards, we are seeking a Quality Assurance (QA) specialist to support the continued compliance with FDA QSR, EU MDR, ISO 13485, and MDSAP for all SprintRay medical devices as well as maintain the Company's Quality Management System and follow regulatory guidance to ensure standards and requirements are consistently met.

Key Responsibilities

●  Provide QA support to ensure compliance with ISO 13485 MDSAP, FDA QSR, EU MDR, and all applicable RoW (Rest of World) requirements for SprintRay medical devices.

●  Maintain the Company's Quality Management System (QMS).

●  Provide real-time quality support to manufacturing to ensure uninterrupted production activities.

●  Perform disposition of nonconforming product, including material review board (MRB) participation as applicable.

●  Support investigations related to production issues and deviations.

●  Support CAPA initiation, implementation, effectiveness checks, and closure.

●  Trend and analyze quality data to identify recurring issues and improvement opportunities.

●  Assist with process validation activities (IQ/OQ/PQ), including protocol execution, data review, and report generation.

●  Support equipment validation and requalification activities.

●  Participate in change control activities related to manufacturing processes and equipment.

●  Support risk management activities related to process changes.

●  Contribute to continuous improvement initiatives focused on product quality, efficiency, and compliance.

●  Support internal audits and regulatory inspections as needed.

●  Assist with development, review, and maintenance of SOPs, work instructions, and quality records.

●  Support quality metrics tracking and reporting.

●  Ability to work cross-functionally with Manufacturing and R&D.

Required Qualifications

●  3+ years of quality experience in a regulated manufacturing environment (medical device preferred).

●  Bachelor’s degree in Engineering, Life Sciences, or a related technical field (or equivalent experience).

●  Working knowledge of ISO 13485 and FDA QSR (21 CFR Part 820)

●  Strong documentation and technical writing skills.

●  Experience with trending, data analysis, and quality metrics.

●  Comfortable working in a cross-functional environment as well as independently.

●  May require up to 30% travel to other SprintRay facilities.

●  Highly organized, detail-oriented, with strong time management skills.

●  Excellent written and verbal communication skills in English.

Employment Type

Fulltime, Onsite

About SprintRay

SprintRay is rewriting the rules of dentistry with technology that’s smart, fast, and designed to make life easier for dental professionals. Since 2014, we’ve been on a mission to deliver the most advanced 3D printing solutions in the industry—combining hardware, software, and materials into one seamless ecosystem.

But what really makes SprintRay different is our people. We’re a bold, global team of innovators, problem-solvers, and doers who thrive on pushing boundaries and challenging the status quo. Every product we create is driven by a simple goal: help dentists spend less time on repetitive tasks and more time changing patients’ lives.

Our culture is entrepreneurial, collaborative, and fueled by curiosity. We celebrate diverse perspectives and believe the best ideas can come from anywhere. Whether we’re building next-generation AI tools, designing new materials, or supporting our customers on the front lines, we’re united by the same passion—transforming digital dentistry and having fun while we do it.

At SprintRay, the future of dentistry is being printed today. Want to be part of it?