Quality Control Manager

4 days ago

Karachi, Sindh, Pakistan beBee Careers Full time

Quality Control Manager Position Overview

The Quality Control Manager will oversee quality control activities in a medical device manufacturing facility. This role includes managing a team, coordinating testing, improving quality processes, and supporting other departments like Quality Assurance and technical problem resolution.

Key Responsibilities:

  • Supervise and support QC inspectors and technicians to ensure adherence to standards and prevent delays or product unavailability.
  • Develop and implement quality control procedures to ensure compliance with ISO 13485 and regulatory requirements, demonstrating technical proficiency in analytical methodology and adherence to GMP and ICH standards.
  • Ensure timely disposition of raw materials, packaging materials, and finished products based on priorities set with Manufacturing, Marketing, and Materials Management, while overseeing inspection and testing to meet quality and efficiency standards.
  • Review the daily QC Lab planning schedule, monitor adherence to quality standards, regulations, and best practices, and perform regular audits of QC processes.
  • Gather and 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.
  • Oversee Quality Risk Management and Change Controls within the QC and Micro Lab domains, identifying areas for improvement and implementing changes to enhance product quality and manufacturing processes.
  • Ensure all vendors are qualified and comply with vendor standards, collaborating with suppliers to maintain material quality and conducting evaluations and audits as necessary.
  • Assist in preparing for and participating in external audits and inspections, providing required documentation and evidence of compliance.
  • Maintain accurate records of quality control activities, including inspection and testing reports.
    • Required Skills and Qualifications:
      • A degree in pharmacy, biomedical engineering, or biotechnology recognized by relevant authorities.
      • 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, regulatory requirements, and other relevant standards for medical device manufacturing.
      • Exceptional leadership and team management skills, strong analytical and problem-solving abilities, meticulous attention to detail, and effective communication skills required.

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