Job Overview:
We are seeking a Quality Assurance Technician to support our manufacturing lines in ensuring compliance with regulatory standards. This role involves performing production audits, handling non-conformances, and reporting quality metrics.
Key Responsibilities:
Perform production audits, inspections, and ensure adherence to Good Manufacturing Practices (GMP)
Manage non-conforming materials and participate in root cause investigations Maintain and report quality metrics Support internal/external audits and regulatory compliance Assist in documentation, process improvements, and lean initiatives
Requirements:
Bachelor's degree in a quality-related field preferred 2-5 years' experience in a regulated manufacturing environment Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR Excellent communication and documentation skills