QC Supervisor

Quality Control Manager Job Description

This role involves overseeing quality control activities in a medical device manufacturing facility, ensuring products meet high standards, regulatory requirements, customer expectations, and quality management system (QMS) compliance.

Key Responsibilities:

• Manage a team of QC inspectors and technicians to ensure adherence to company standards and prevent delays or product unavailability.
• Develop and implement quality control procedures to ensure compliance with ISO 13485 and DRAP regulations, demonstrating technical proficiency in analytical methodology and adherence to GMP and ICH standards.
• Oversee the timely disposition of raw materials, packaging materials, and finished products based on priorities set with Manufacturing, Marketing, and Materials Management, while monitoring inspection and testing to meet quality and efficiency standards.
• Conduct daily QC Lab planning schedules, monitor adherence to quality standards, regulations, and best practices, and perform regular audits of QC processes.
• Analyze quality data, generate reports, and suggest actions for quality improvement.
• Investigate quality issues or non-conformities and collaborate with other departments to resolve them.
• Implement Quality Risk Management and Change Controls within the QC and Micro Lab domains, identifying areas for improvement and enhancing product quality and manufacturing processes.
• Evaluate and audit vendors to ensure they are qualified and compliant with vendor standards, maintaining material quality and collaborating with suppliers as necessary.
• Prepare for and participate in external audits and inspections, providing required documentation and evidence of compliance.
• Document quality control activities, including inspection and testing reports.
  • Requirements:
    • A degree in pharmacy, biomedical engineering, or biotechnology recognized by HEC.
    • A minimum of 5-6 years of experience in quality control and testing, preferably within a medical device manufacturing environment, with at least 4 years in a supervisory position.
    • Certification in quality control or quality management systems is preferred.
    • In-depth knowledge of ISO 13485, DRAP regulations, and other relevant standards for medical device manufacturing.
    • Strong leadership and team management skills, analytical and problem-solving abilities, attention to detail, and effective communication skills required.