Quality Control Manager – Global Opportunity

About the role

The Quality Control (QC) Manager will lead the QC function for Microhaem Scientifics, ensuring that all medical device products and processes meet rigorous quality standards. Reporting to the QMS Director, the role spans release testing, stability programs, method transfers, and validation activities across internal and external laboratories.

Key responsibilities

• Establish and maintain a comprehensive QC system aligned with ISO 13485, WHO and other regulatory requirements.
• Design, implement, and update QC processes, analytical methods, protocols and reporting templates.
• Develop testing and inspection procedures to detect and correct deviations.
• Review and approve development, release and stability data for routine manufacturing and investigations.
• Act as the primary technical liaison with external testing laboratories and Contract Development Organizations.
• Ensure all QC activities are performed in compliance with regulatory standards and customer expectations.

Required profile

• Senior‑level experience (minimum 84 months) in quality control or assurance within the medical device sector.
• Proven ability to lead QC teams and manage cross‑functional projects.
• Strong understanding of regulatory frameworks such as ISO 13485 and WHO guidelines.

Required skills

• Implementation of ISO 13485‑compliant quality control systems.
• Method validation, stability testing, and analytical method development.
• Experience with external laboratory coordination and contract development organizations.
• Data review and approval for product release and investigations.
• Regulatory compliance and documentation management.