Quality Assurance Specialist

About the Role

Our company is looking for a dedicated Quality Assurance Specialist to enhance quality management in a GMP-regulated manufacturing setting. This position plays a critical role in overseeing production quality for assembly, labeling, packaging, and other manufacturing operations to ensure compliance with GMP, ISO 13485 standards, and internal quality guidelines.

Key Responsibilities

• Conduct in-process inspections and ensure line clearances are properly performed.
• Verify equipment functionality and adherence to standards throughout manufacturing processes.
• Implement AQL sampling techniques to assess the quality of finished products.
• Maintain precise Device History Records (DHRs) documenting production activities.
• Investigate and resolve quality issues, supporting root cause analyses.
• Collaborate closely with manufacturing teams to maintain product quality standards.
• Assist with the organization and management of quality documentation.
• Help train new quality control personnel and maintain comprehensive quality records.

Qualifications and Experience

• Minimum of three years’ experience in Quality Control or Quality Assurance roles within medical device, diagnostics, or pharmaceutical manufacturing environments.
• Well-versed in ISO 13485, Good Manufacturing Practices (GMP), and FDA quality systems.
• Strong skills in quality documentation and record keeping.