SprintRay Inc. · 2 days ago
QA Specialist
17601 Sampson Ln, Huntington Beach, Americas, 92647, US
Full-time
Onsite
Mid Level
$90K/yr - $110K/yr
3+ years expSprintRay Inc. is a company focused on delivering advanced 3D printing solutions for the dental industry. They are seeking a Quality Assurance (QA) Specialist to ensure compliance with regulatory standards for medical devices and maintain the company's Quality Management System.
3D PrintingDentalHealth CareMedical Device
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
Qualification
Required
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
Company
SprintRay Inc.
We are a 3D Printer manufacturer focused on digital dentistry.
501-1000 employees
H1B Sponsorship
SprintRay Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (3)
2023 (3)
2022 (12)
2021 (6)
Funding
Current Stage
Late StageLeadership Team
Amir Mansouri
Co-Founder and CEO
Hossein Bassir
Co-founder, Design Director
Recent News
2025-11-10
2025-10-30
Company data provided by crunchbase