QUALITY ASSURANCE SUPERVISOR

Quality Assurance Supervisor is responsible for overseeing the implementation and maintenance of the Quality Management System (QMS) to ensure compliance with ISO 13485, applicable regulatory requirements, and company quality standards. The role supervises Quality Assurance personnel, supports production operations, ensures product quality throughout the manufacturing process, and leads quality improvement initiatives to ensure safe and effective medical devices.

Key Duties and Responsibilities

• Supervise and manage the daily activities of the Quality Assurance team.
• Ensure compliance with ISO 13485, Good Manufacturing Practices (GMP), and applicable regulatory requirements.
• Monitor manufacturing processes to ensure medical devices consistently meet quality specifications and customer requirements.
• Review and approve Device History Records (DHR), batch records, quality reports, and other quality documentation.
• Oversee incoming, in-process, and final inspection activities to ensure product conformity.
• Investigate nonconforming products, quality issues, customer complaints, and returned products.
• Lead root cause investigations and implement Corrective and Preventive Actions (CAPA).
• Ensure timely disposition of nonconforming materials and products.
• Conduct and coordinate internal quality audits and support external audits by customers and regulatory agencies.
• Maintain and improve the Quality Management System (QMS).
• Monitor Key Performance Indicators (KPIs) related to product quality and process performance.
• Ensure proper implementation of document control and record retention procedures.
• Coordinate with Production, Engineering, Regulatory Affairs, Supply Chain, and other departments to resolve quality issues.
• Review change controls and participate in risk management activities.
• Support process validation, equipment qualification, and product validation activities.
• Ensure calibration programs and environmental monitoring activities are effectively implemented.
• Provide training and coaching to QA personnel on quality standards, procedures, and regulatory requirements.
• Prepare quality reports and present quality performance during management review meetings.
• Promote a culture of quality, compliance, and continuous improvement throughout the organization.
• Perform other duties assigned by management.

Qualifications

• Bachelor's degree in Engineering, Industrial Engineering, Biomedical Engineering, Chemistry, Biology, Pharmacy, or a related science field.
• Minimum 5 years of Quality Assurance experience in a medical device manufacturing environment.
• At least 2 years of supervisory experience in Quality Assurance.
• Thorough knowledge of ISO 13485:2016, Quality Management Systems (QMS), and applicable medical device regulations.
• Experience with CAPA, Nonconformance Reports (NCR), Internal Audits, Complaint Handling, Risk Management, and Document Control.
• Knowledge of process validation, equipment qualification (IQ/OQ/PQ), and change control.
• Familiarity with FDA Quality System Regulation (21 CFR Part 820) and other applicable international regulatory requirements is an advantage.
• Strong leadership, analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office and quality management software.