R.A./Q.A.Specialist

Location: On-SiteAt 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 productsImplement and maintain the Company's Quality Management SystemFollow regulatory guidance to ensure standards and requirements are consistently metStay 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 QAPrevious experience in Medical DevicesPrevious experience working in a RA-QA-related function Previous experience with implementation of a Quality Management SystemStrong knowledge and understanding of ISO 13485, MDSAP, and FDA QSR complianceUnderstanding Quality Management SystemKnowledge and understanding of regulatory affairsStrong knowledge and understanding of ISO 13485, MDSAP, and FDA QSR complianceBS in Chemical or Biomedical Engineering or a related fieldExtremely organized and detailed orientedHave great time management skillsHave excellent written and verbal communication skills in EnglishBe a team player, as well as being able to work independently Target Salary Range: $78,000-$142,560Actual 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.