Integrated Talent Strategies (ITS) has a client in the Columbus, OH area that is seeking a Quality Engineer.
-Collaborate with Principal Investigator to develop and implement protocols, plans, informed consent forms (ICF), etc.
-Develop and implement forms and documentation to meet requirements of new studies with investigational medical devices
-Plan and oversee daily administrative and research activities for investigational medical devices
-Assist or lead training and re-training of newly hired as well as current research staff
-Supervise research data collection, management, and reporting
-Assist with activities to ensure compliance with Institutional Review Boards (IRB)
-Ensure compliance to federal, state, and local regulations and guidelines
- Plan, coordinate, and participate in site visits by research sponsors and regulatory agencies, as needed
-Support group QS conformance and lead project QS conformance
-Contribute to group regulatory compliance
-Support project regulatory compliance and project conformance to applicable standards
-Support risk management activities both on projects and within the QS
-Lead test execution and conformance to requirements
-Identify situations where a statistician may be needed and assist in coordination of a statistician to execute statistical modeling, develop statistical rationale, and select appropriate statistical methods
-Interpret basic to moderate statistical calculations that have been performed by someone else
-Execute basic statistical calculations
-Act as liaison between medical device design and manufacturing to assure transfer is smooth and responsibilities are managed and executed
-Lead continuous improvement efforts to reduce the cost of execution, cost of compliance, and cost of quality for the organization
Bachelor’ s degree; five years of experience; or an equivalent combination of education and or experience in a related field; technical writing experience (writing sample may be required).
Three years of experience in related industry (in a medical device capacity). One year of specific experience as a Clinical Research Associate or equivalent.
Five years of specific experience as a Clinical Research Associate or equivalent for investigational medical devices.
About Integrated Talent Strategies (ITS)
ITS is an international recruiting and staffing firm specializing in Engineering, Technical and Professional positions. Founded in 1984 as a subsidiary of an engineering firm, ITS continues to remain a strategic partner for the job seeker.
Our clients include some of the largest and most respected architectural, engineering, and manufacturing companies in business today. Our ability to offer a wide range of services, and the flexibility to adjust to the changing needs of our clients, has allowed us to maintain a solid reputation for several decades.