Job Description

The Quality Control (QC) Supervisor is responsible for supervising and coordinating all quality control activities throughout the sterile processing workflow to ensure reusable medical devices and surgical instruments are cleaned, inspected, assembled, packaged, sterilized, and released in accordance with approved procedures, customer specifications, and applicable regulatory requirements. The role is critical in minimizing customer complaints, preventing non-conforming products, ensuring patient safety, and maintaining compliance with ISO 13485, ISO 9001, ISO 17665, MSQH, MSSA, and other applicable standards.

1. Quality Control Operations

• Supervise daily Quality Control activities across all operational shifts.
• Verify that all reusable medical devices are thoroughly cleaned, free from soil, stains, rust, and other defects before release.
• Ensure all instruments are complete, functional, correctly assembled, lubricated (where applicable), packaged, labelled, and sterilized according to approved procedures.
• Perform and supervise final inspection of processed instrument sets prior to release.
• Ensure all processed products comply with customer requirements and internal quality standards.

1. Customer Complaint Prevention

• Monitor product quality to minimize customer complaints, rejected instrument sets, and rework.
• Investigate customer complaints and quality issues using Root Cause Analysis (RCA).
• Implement and monitor Corrective and Preventive Actions (CAPA).
• Monitor complaint trends and recommend continual improvement initiatives.

1. Compliance and Quality Management System

• Ensure compliance with ISO 13485:2016, ISO 9001:2015, ISO 17665, MSQH Standards, MSSA Guidelines, customer requirements, and company SOPs.
• Maintain complete and accurate quality records and documentation.
• Support internal audits, customer audits, certification audits, and regulatory inspections.
• Participate in risk assessments, validation activities, change control, and continual improvement programmes.

1. Team Leadership

• Ensure adequate QC coverage for 24-hour operations.
• Promote a strong quality culture and compliance with established procedures.

1. Reporting and Performance Monitoring

• Prepare daily, weekly, and monthly quality reports.
• Monitor quality indicators, including customer complaints, rejected sets, sterilization failures, non-conformities, rework, and audit findings.
• Analyse trends and recommend improvement initiatives to enhance process performance and customer satisfaction.

Qualification / Requirement

Professional certification in CSSD or Sterile Processing is an advantage.

• Good knowledge in ISO 9001 and ISO 13485 is preferred.
• 0-2 years relevant experience.
• Experience in healthcare support services / CSSD / sterile processing / hospital operations preferred.
• Knowledge in:
• ISO 9001 / ISO 13485
• MSQH standards
• Risk management
• Facilities management
• Maintenance planning
• Infection control
• CAPA & RCA
• Good leadership, communication, and problem-solving skills.
• Able to manage cross-functional coordination and audits.
• Proficient in report preparation and documentation control.