Quality Assurance (QA) Specialist

Location: Huntington Beach, CA
Compensation: $100,000 – $110,000 annually (depending on experience)

About the Role

At SprintRay, we are in a high-growth phase and constantly seeking ways to maintain the quality of our products and processes while scaling at an extraordinary pace. To uphold our regulatory and quality standards, we are looking for a Quality Assurance (QA) Specialist to support compliance with FDA QSR, EU MDR, ISO 13485, and MDSAP for all SprintRay medical devices. This role will also be key in maintaining and improving our Quality Management System (QMS) and ensuring standards and requirements are consistently met.

Key Responsibilities

• Provide QA support to ensure compliance with ISO 13485, MDSAP, FDA QSR, EU MDR, and other applicable global regulations for SprintRay medical devices.
• Maintain and continuously improve the Company’s Quality Management System (QMS).
• Apply changes to Quality Management System (QMS) documents as directed by the RA/QA Lead or designee.
• Participate in internal audits and support the RA/QA team lead during external audits.
• Review and assess product labels, Instructions for Use (IFU), and Safety Data Sheets (SDS) for regulatory compliance.
• Provide input and documentation support for management review meetings to ensure alignment with quality and regulatory requirements.
• Collaborate with cross-functional teams (e.g., R&D, Marketing) on new product development projects.
• Implement, maintain, and improve supplier qualification processes.
• Implement, maintain, and improve distributor qualification processes.
• Implement, maintain, and improve medical device risk assessments.
• Review controlled documents from various departments for compliance and accuracy, including:
• Design control documents
• Process validation documents
• Controlled document naming/numbering assignments
• Document change control tracking and maintenance
• Maintain accurate records of all controlled documents.

Required Qualifications

• 5+ years of experience in Quality Assurance and medical device compliance.
• Direct experience in the medical device industry.
• Proven experience with the implementation and maintenance of a QMS.
• Strong knowledge of ISO 13485 and regulatory quality standards.
• Familiarity with regulatory affairs principles and their impact on QA.
• Bachelor’s degree in engineering or a related field.
• Highly organized, detail-oriented, with strong time management skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Excellent written and verbal communication skills in English.
• Ability to work both independently and as part of a collaborative team.

Employment Type

Full Time

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?