Ensures site activities associated with medical device manufacturing and testing comply with quality management systems and applicable regulatory requirements. Coordinates Quality Management Systems ensuring compliance to all relevant regulations and standards including FDA QSR Part 820; including change management, record retention, training, and assist with the internal audit program.
The list of essential functions, as outlined herein, is intended to representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.
To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION AND/OR EXPERIENCE:
Associates degree from an accredited college or university and two (2) years of experience in a laboratory or blood bank environment as well as prior customer relations experience or an equivalent combination of education, training and/or experience.
CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS:
KNOWLEDGE, SKILLS AND ABILITIES:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Functions involve the ability to exert light physical effort in sedentary to light work, which may involve some lifting, carrying, pushing and/or pulling of objects and materials of light weight (up to 20 pounds).
The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job.
Functions are regularly performed inside without potential for exposure to adverse conditions, such as inclement weather, atmospheric elements and pathogenic substances.