
System Quality Specialist Position
3 days ago
This position requires coordination of the change control documentation and approval process. The successful candidate will also provide quality support for technology transfer and improvement of existing processes. This includes conducting investigations, collecting data, analyzing trends, and preparing reports for assigned quality processes.
Duties and Responsibilities:
- Responsible for key processes such as CAPA/NC coordination and monitoring, Training SME, and Quality Systems SME
- Responsible for reporting metrics related to areas of support to appropriate review boards
- Manage, maintain, improve, and standardize processes under role responsibility to support ensuring compliance with FDA regulations, ISO Standards, and all applicable regulatory authorities' requirements
Requirements:
- University/Bachelor Degree of Science or Engineering field
- 3+ years of experience in medical device manufacturing or related industry
- Demonstrated knowledge of quality system principles, practices, and processes
Preferred Qualifications:
- Prior experience in ISO 13485 and/or QSR 820 FDA regulated environment
- Excellent interpersonal relations and communication skills
About the Role:
This is a mid-senior level full-time position requiring strong leadership skills and ability to work cooperatively with coworkers and diverse teams.
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