This positions reports to the QA/QC Manger and shall be responsible to shared duties between the Quality and Operations systems. Responsible to maintain company-wide Quality Systems (QMS) Must have a thorough understanding of the Quality Policies of the company and ensure the other departments are in compliance with our procedures. Must have experience with NC/CAPA systems and the Design Control process. The position will provide Quality and Regulatory support to the manufacturing and R&D activities within the company.
- B.S degree, M.S degree preferred .
- Experience with the execution of quality systems like CAPA, NCMR, deviations and document control
- Experience with Medical Device inspection and testing
- Knowledge of Quality Systems regulations including 21 CFR 820 and ISO 13485
- Excellent skills in organization, record keeping and communications
- High level of experience and understanding of GMP/GLP system requirements
- Excellent oral and written communication skills
- Collaborative and proactive attitude a must
- Able to adapt to a fast-paced work environment and must have a strong work ethic to complete assignment with high quality under tight deadlines
- Work with QA/QC manager to execute and maintain the NC/CAPA system
- Perform verification testing on manufacturing materials
- Provide Quality support to the QMS activities within the company specifically the Design Control process
- Working on multiple, simultaneous projects, which require you to be able to manage time flexibly and interact with a variety of people