Marlborough, MA16 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 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
Bachelor's Degree (Required)
License/Certifications
ASQ Certification preferred
Regulatory Affairs Certification (RAC) preferred
.