In this role, you will coordinate and ensure with all the site subcontractors and vendors that quality requirements for the contract are met; participate in the sites internal and external site audits.
In this role, you will be responsible for release of raw material, production support, finished product, and stability samples - Author and review laboratory investigation reports, deviations, and technical documents - Perform forecasting for resource and stability needs.
This QA/RA role is responsible for supporting R&D project teams through the New Product Development process for various medical devices at Hill-Rom's Acton MA Business site. This position will also be responsible for participating on various Design Assurance improvement initiatives to improve the overall quality of new product designs and the company's regulatory compliance profile per 21CFR820 regulations.
In this role, you will be responsible for the personnel functions of the Quality Associate(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all personnel records, management of work schedule and delegation / follow - up of tasks.
In this role, you will implement and supervise technical quality (i.e., adherence to client, regulatory agency, and company requirements), perform administrative functions (i.e., budgeting, forecasting, staffing, etc.), and help to maintain harmonious client relations.