Job Details Job Location Devens - Devens, MA Position Type Full Time Education Level 2 Year Degree Description By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics. Position Summary: The QA/RA Administrator is responsible for reviewing and updating Quality Management System to align with current regulatory standards and guidance documents applicable to IVD/Medical Device (FDA 21 CFR 820, ISO13485: current, MDSAP, IVDR, etc.) conducting internal quality audits, supplier audits, corrective and preventive actions, complaint handling and non-conforming material process. Key Responsibilities: Primarily responsible for compliance to the FDA Quality System Regulation and applicable ISO standards. Prepare responses to customer requests for items such as; Certificates of Origin, country registration forms, Declarations, etc. Maintain CE registrations and Technical Files as required. Assist QA and Supply Chain personnel with the internal audit program by preparing audit schedules, agendas, and metrics for senior management. Perform internal audits; generate audit reports and follow-up on audit observations. Ensure completion of audit documentation in a timely manner according to existing procedure. Administer corrective and preventive action; issue CAPAs resulting from internal audits, supplier audits, NCMRs and other areas; monitors corrective action plans, verify the effectiveness of preventive and corrective actions as required by performing audits or assigning audits as part of audit planning. Administer complaint handing process, including intake of complaint, initial review and acknowledgement, assignment and follow-up, closure and final reporting. Create, revise, and review SOPs and documents needed for cGMP compliance. Prepare and conduct training in Good Manufacturing Practices for Bio-Techne employees. Qualifications Education and Experience: Associates Degree or higher with a minimum of 3 to 5 years Quality Assurance and Regulatory Affairs work experience in Medical Device including FDA CFR 820, ISO 13485:current, MDSAP, IVDR, etc. Competent with all aspects of a Quality Management System including CAPA, NCMR, MRBs, System auditing standards and procedures. Experience writing training programs, reports, and documents. Effective verbal skills for training and communications with personnel at all levels, both inside and outside the organization. Ability to perform in a fast paced and demanding environment. Effective oral and written communication skills targeted at all levels within the company. Including strong skills in interpersonal, collaborative team building, meeting facilitation and presentation. Experienced in the use of personal computer, including high level of proficiency in Microsoft Word, Excel and PowerPoint. Training and auditing experience is required.