Quality Control Leader for Medical Devices

5 days ago

Karachi, Sindh, Pakistan beBee Careers Full time

Job Description:

Kamion-Pharma is seeking a Quality Control Manager to oversee quality control activities in our medical device manufacturing facility.

Key Responsibilities:

  • Team Leadership: Supervise and support QC inspectors and technicians to ensure adherence to company standards, prevent delays or product unavailability.
  • Quality Process Development: 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.
  • Inspection and Testing: Ensure the 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.
  • Audit and Compliance: Review the daily QC Lab planning schedule, monitor adherence to quality standards, regulations, and best practices, perform regular audits of QC processes.
  • Product Stability Evaluation: Ensure the implementation of the product stability testing & evaluation as per SOP to verify shelf-life compliance and identify quality issues related to product stability.
  • Data Analysis: Gather and analyze quality data, generate reports, and suggest actions for quality improvement.
  • Quality Issue Investigation: Investigate quality issues or non-conformities and collaborate with other departments to resolve them.
  • Vendor Qualification: Ensure all vendors are qualified and comply with vendor standards, collaborating with suppliers to maintain material quality and conducting evaluations and audits as necessary.
  • External Audits: Assist in preparing for and participating in external audits and inspections, providing required documentation and evidence of compliance.
  • Record Maintenance: Maintain accurate records of quality control activities, including inspection and testing reports.

Required Skills and Qualifications:

  • Bachelor's degree in pharmacy, biomedical engineering, or biotechnology from a recognized institution.
  • Minimum 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 (e.g., CQE, CQA) is preferred.
  • In-depth knowledge of ISO 13485, DRAP regulations, 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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