This position will support daily Quality Assurance operations to assist with implementing and maintaining the effectiveness of the Quality System.
This position serves as principal Quality Assurance (QA) personnel to assist with implementing and maintaining the effectiveness of the Quality System. This position performs various quality-engineering functions and associated support tasks in driving business objectives, developing knowledge and experience in the areas of 21 CFR 820 and 803, ISO 9001-13485, and MDD. This includes working to support Design Control projects as well as other duties in support of the Quality System, Document Control, Manufacturing department, and Investigations (CAPA, Complaints, Nonconformance, and Unscheduled Maintenance).
To perform this job successful, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle of feel. The employee is occasionally required to stand and reach with hands and arms and lift or move up to 25 lbs. Vision requirements include the ability to see and interact with computer as well as close vision.
This work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position works in an office and manufacturing environment. The noise level in the work environment is quiet to moderate. May include manufacturing or lab environment and certain work areas contain radioactive or hazardous chemicals.