R.A./Q.A. Specialist

Location: Huntington Beach

On-SiteRegulatory Affairs (RA) – Quality Assurance (QA) Specialist for leader in dental 3D printing & digital dentistry solutions.  Duties are maintaining ISO 13485, MDSAP and FDA QSR regulatory & quality compliance standards for medical device manufacturing including drafting, implementing & maintaining QMS in accordance with FDA QSR regulations; assisting with preparing 510(k), EU-MDR, CE marking, technical files & post market surveillance reports for medical devices;  and conducting internal audits to ensure quality standards & requirements.  Requirements are Bachelor’s degree in Healthcare Regulatory Compliance, Healthcare Decisions Analysis, Biomedical Engineering or related field and 3 yrs exp in stated job duties. 

Salary range is $80,000 to $90,000.  

SprintRay is a forward-thinking, nimble company on a journey to provide digital dentistry solutions to our customers. Since 2014 we have produced products that are advanced, user-friendly, and offer a premium experience. Our organization is customer-centric, high-performing, and globally diverse. Challenging assumptions by identifying and solving problems is our way of life. We leverage conventional and unconventional wisdom with an entrepreneurial spirit that leaves no stone unturned as we develop the highest quality products, services, and relationships. For us to stamp our name on a product, it must be carefully considered, targeted, and meticulously designed to solve our customers’ most pressing problems and pave the way for the future. We work to continuously redefine the rules for our industry through our passion for technology, innovation, and our community. We have bold ambition and work to stay connected to what’s happening on the front lines of our business so that the needs of our customers are always being met.

To All Recruitment Agencies:

SprintRay does not accept agency resumes. Please do not forward resumes to company email addresses or other company contacts. SprintRay is not responsible for any fees related to unsolicited resumes. Unsolicited resumes received will be considered our property and will be processed accordingly.

SprintRay is an equal opportunity employer.