Location: On-Site
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.
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:
- 3+ years of experience in regulatory compliance and QA
- Previous experience in Medical Devices
- 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
- Strong knowledge and understanding of ISO 13485, MDSAP, and FDA QSR compliance
- BS in Chemical or Biomedical 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
Target Salary Range: $64,480-$81,000
Actual compensation packages consider a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The estimate provided has not been adjusted for all of these factors. At SprintRay, it is not typical for an individual to be hired at or near the top of the range for their role. The total compensation package for a position may also include an annual performance bonus, medical/dental/vision benefits, and/or other applicable compensation.
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.
To All Recruitment Agencies:
Without a written agreement signed by an officer of SprintRay: a) SprintRay does not accept resumes from recruiting agencies, headhunters, or any other party expecting payment in the event SprintRay speaks with or hires a candidate from such submitted resume; b) SprintRay is not responsible for any fees related to unsolicited resumes or related Terms of Service, and c) Unsolicited resumes received will be considered the property of SprintRay and will be processed accordingly.
What We Do
As the innovation and sales leader in a hyper-competitive field, SprintRay profoundly influences the overall direction of the 3D dental printing industry. It is also a 2022/2023 Great Place to Work®. When you join the SprintRay employee family, your expertise and talents merge with those of highly competent colleagues who share your passion for elegant design, constant improvement and application of best practices in manufacturing, and incorporating additive manufacturing and AI into digital hardware production and services. Professionals in every division work together to contribute both quantitatively and intangibly to their company’s success, whether they’re involved with marketing SprintRay products and services, developing new resins or 3D printing components, customer service, or ensuring a friendly workplace. A generous benefits package helps maintain a healthy work-life balance and personal harmony. The rewards for helping SprintRay become the name synonymous with 3D digital dental printing go beyond standard compensation packages as measured by stock options that allow employees to capitalize generously from their hard work.
As a Brand Ambassador, multiple Gold Medal sprinter and World Record holder Usain Bolt is the living embodiment of the unique status of SprintRay as the trailblazer and pacesetter in pioneering end-to-end 3D printing ecosystems for dental professionals. Above all else, Usain’s philanthropic work in his native Jamaica exemplifies the compassion and humanity SprintRay actively cultivates in its workers worldwide. Tell us how you will help us sustain our market leadership and make the world a better place.
Why Work With Us
SprintRay employees collaborate with thought leaders in the dental industry to bring the convenience, comfort and health benefits of 3D printing to individuals and families around the world. While global access to technological breakthroughs are Priority 1, SprintRay also includes the happiness and welfare of its workers in its overall mission.
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