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Quality Technician
3 months ago
Job Title: Quality Assurance Specialist
Company: Medical Device Innovations
The QA Specialist plays a key role in ensuring the company's Quality Management System remains compliant with Medical Device Directives, Regulations, and quality standards. Responsibilities include:
- Contribute to strategic improvement projects aligning with regulatory requirements
- Present Quality Data to analyze trends and support investigations
Tasks involve managing Document Control, CAPA, Vigilance, Risk Management, Internal Audit, Post-Market Surveillance, Supplier Monitoring, and Product Release activities. Additional duties include:
- Maintain communication with subcontractors and suppliers
- Analyze data from various sources for meaningful insights
Moreover, the role entails collating and reviewing batch records, certificates of analysis, sterilization data, and overseeing Customer Complaints and Regulatory activities. The QA Specialist also prepares and analyzes data for Management Review while staying updated on the latest Quality Management System and Regulatory Requirements.