Quality Assurance (QA) Engineer

Responsibilities:

• Maintain and control documentation required by the Quality Management System (QMS).
• Monitor performance of subcontractors and ensure adherence to quality standards.
• Collaborate with Operations and QC to address issues identified during record reviews, equipment usage, and deviations.
• Initiate and manage nonconformance reports (NCRs), corrective and preventive actions (CAPAs), engineering change orders (ECOs), and production records within the QMS framework.
• Conduct employee training sessions per the annual plan and documentation updates.
• Support preparations for internal, supplier, and external audits.

Requirements:

• Academic degree in engineering or scientific discipline / CQE certification.
• Minimum 2 years of experience in QA roles in the medical device, pharmaceutical, or related industries.
• Strong English skills (written and verbal).
• Proficient in Microsoft Office tools (Excel, PowerPoint, Word).
• Preferred: familiarity with ISO 13485:2016, EU MDR (2017/745), and FDA 21 CFR Part 820.