Description
Title: QA Engineer III - FL
Location: Gainesville, FL
Rate: $34.00/hr - $41.00/hr on w2
Duration: 5 Months with the possibility of extension
Education:
- Bachelor's Degree
Description:
- Train internal personnel in QA program requirements. Prepare monthly QA status reports. Participate in customer and regulatory agency audits. Proficient knowledge of ISO13485, FDA 21 CFR 820 and relevant medical device regulations.
Job Specifics:
- Quality Engineer III dedicated to CAPA remediation.
- Ensure CAPA action plans are robust and executed promptly, with the appropriate sense of urgency.
- Ensure CAPA documentation meets Good Document Practices and is a complete and accurate record of CAPA actions.
- Identify and execute recommended quality improvements.
Knowledge/Skills:
- Expert knowledge of standards and regulations applicable the complete life cycle of a medical device.
- Strong knowledge of quality assurance principles and practices, industry and international safety standards
- Excellent communication (verbal & written) skills
- Must practice analytical problem solving skills
- Able to exercise judgment against the criteria of applicable regulations and standards
- Proactive and able to act on own initiative
- Excellent organizational skills.