R.A./Q.A. Specialist

Location: Westminster

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 grow and maintain the regulatory and quality standards, we are seeking a Regulatory Affairs (RA) and Quality Assurance (QA) specialist to provide RA-QA support and leadership to ensure compliance with FDA QSR, ISO 13485, and MDSAP for all SprintRay products as well as implement and maintain the Company's Quality Management System and follow regulatory guidance to ensure standards and requirements are consistently met. 

Successful candidates will have a BS in Chemical or Bio-medical Engineering or a related field and previous experience in Medical Device and RA-QA role and experience with implementation of a Quality Management System. In addition to having a strong knowledge and understanding of regulatory submissions (i.e., 510(K), EU MDR, CE marking), ISO 13485, MDSAP, and FDA QSR compliance.

Job Description:

• Provide RA-QA support to ensure compliance with ISO 13485 MDSAP, and FDA QSR for all products
• Implement and maintain the Company's Quality Management System
• Follow regulatory guidance to ensure standards and requirements are consistently met
• Stay up to date with the new regulations for the medical device manufacturing companies 
• Helping the RA-QA team in regulatory submissions

Requirements:

• Previous experience in Medical Device
• Previous experience working in a RA-QA-related function 
• Previous experience with implementation of a Quality Management System
• Strong knowledge and understanding of ISO 13485, MDSAP, and FDA QSR compliance
• Understanding Quality Management System
• Knowledge and understanding of regulatory affairs
• Previous experience with regulatory submissions such as 510(k), EU-MDR, CE marking, preparation of technical files and post market surveillance reports.
• BS in Chemical or Bio-medical Engineering or a related field
• Extremely organized and detailed oriented
• Have great time management skills
• Have excellent written and verbal communication skills in English
• Be a team player, as well as being able to work independently

About SprintRay

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.