BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Quality Assurance Specialist to work for a leading San Diego biotechnology company.
Quality Assurance Specialist
The Quality Assurance Specialist provides support for the corporate Quality System and quality related tasks. Ensures conformance of product performance to specifications and compliance with applicable regulatory and standards (ISO 9000 or ISO 13485) requirements through auditing and other activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Maintain the Quality System in accordance with applicable regulations and standards as documented in Company policies and procedures including, but not limited to the Calibration System, Training System, Process Control System, Documentation Maintenance System.
Assist the QA department and company in the implementation and use of policies and procedures that meet the Quality System requirements.
Audit the conformance of the Quality System and products to established requirements and provide periodic reports to management.
Apply Quality assurance principles to the identification and correction of nonconformance, including use of formal corrective/preventive action.
Enhance customer satisfaction through reporting of quality status and facilitation of continuous improvement of company product and services.
EDUCATION and/or EXPERIENCE
Good understanding of Microsoft Word, Excel and Access software, GMP (Good Manufacturing Practices) knowledge and experience, Previous experience in Medical Device Field a plus, 2 Year Degree or at least 2 years work experience in an ISO 9000 or ISO 13485 Quality Assurance System.