Marlborough, MA16 days ago
Knowledge: Experience with quality management system development, Design Controls, and risk management Skills: 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 solving Competencies: 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 objectives Business 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 communication Education Bachelors Degree (Required) License/Certifications ASQ Certification preferred Regulatory Affairs Certification (RAC) preferred Hybrid, required 3 or 4 days in office in Marlborough MA Experience in Medical Devices design and development with a strong focus on design control and risk management is preferred There is potential for this to turn into a direct role with Client.