Marlborough, MA21 days ago
IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA).Knowledge:Experience with quality management system development, Design Controls, and risk managementSkills:Communication (verbal and written), ability to build and manage an effective team, being able to influence others and drive for results, effective presentation skills, problem solvingCompetencies:* Demonstrate ability to influence and create change* Strong interpersonal communication skills* Demonstrate strong writing and composition skills* Demonstrate success in motivating team members to reach objectivesBusiness Process Skills* Able to effect Quality Improvement through problem solving skills and knowledge of quality tools* Able to lead and drive change* Organization skills* Project and team management skills* Analytical and problem-solving skills* Proficient in Microsoft Word, Excel, and Powerpoint* Able to function in a matrix organization* Flexibility to meet continuously changing priorities and challenges* Requires ability to understand, interpret and apply quality and regulatory requirements. Work Environment:* Prolonged sitting at a desk (i.e., operating a computer, telephone use, document review)* Walking or standing within the office area to operate other office equipment (i.e. printer / fax) or within the laboratory* Required to wear PPE as appropriate when visiting testing locations* Must frequently respond to text/email communications and will be required to be aware of ergonomic principles* May be required to travel by airplane /train or drive long distances* Ability to follow verbal or written instructions and use effective verbal and written communicationEducationBachelor's Degree (Required)License/CertificationsASQ Certification preferredRegulatory Affairs Certification (RAC) preferred .