R.A./Q.A. Specialist HQ

Company: SprintRay Inc.
Location: Huntington Beach
Posted on: September 1, 2024

Job Description:

On-Site Regulatory Affairs (RA) - Quality Assurance (QA) Specialist for a leader in dental 3D printing & digital dentistry solutions. Duties include 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:

• Bachelor's degree in Healthcare Regulatory Compliance, Healthcare Decisions Analysis, Biomedical Engineering or related field
• 3 years of experience in stated job dutiesSalary range: $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. 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.SprintRay is an equal opportunity employer.About SprintRay: SprintRay is a highly collaborative environment where innovative people have the freedom to satisfy their curiosity by finding creative solutions to hard problems. If you are a relentless problem solver who wants to shape the future of 3D printing, join SprintRay! Together, we can revolutionize the next 100 years of manufacturing and empower future generations of doctors, designers, and makers all over the world.
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Keywords: SprintRay Inc., Huntington Beach , R.A./Q.A. Specialist HQ, Other , Huntington Beach, California