About Us
DUTIES / RESPONSIBILITIES (Listed in order of importance)
- Perform data entry and prepare reports / graphs related to special projects, CA, PA, Audits, NCR’s, Deviations, Training, etc.
- Maintain accurate documentation and files related to special projects, CA, PA, Audits, NCR’s, Deviations, Training, etc.
- Review and approve Lot documentation for Lot Release activities and maintain files.
- Support Database development, implementation and validation activities.
- Excellent communication skills with ability to interface at all levels professionally.
- Participate in Internal Audits.
Critical Knowledge and Skills
- Strong attention to detail and accuracy.
- Strong organizational, communication, analytical, and technical writing skills.
- Strong working knowledge of database, word processing, and spreadsheet programs.
- Knowledge and application of the Quality System Regulation (FDA).
- Familiarity with the ISO 9001 and ISO 13485 standards for quality systems, especially sections pertaining to CA, PA, Audits, NCR’s, Deviations, Training and Lot Release.
Educational Requirements
- Minimum AS degree, preferably in an engineering/scientific/computer systems/ or quality management curriculum
- 2-4 years related experience in a regulated environment, preferably medical devices.
- Working knowledge of the Quality System Regulation (FDA QSR 21 CFR Part 820) ISO 13485 quality system standards
