Medical Device Quality Assurance Manager

3 days ago

Karachi, Sindh, Pakistan beBeeQuality Full time
Job Title: Quality Assurance Manager

Location: SITE, Super Highway, Phase-II, Karachi

Job Overview:

The Quality Assurance Manager will be responsible for overseeing quality assurance activities in a medical device manufacturing facility, ensuring products meet high standards, regulatory requirements, customer expectations, and QMS compliance. This role includes managing a team, coordinating testing, improving quality processes, and supporting other departments like Quality Control and technical problem resolution.

Key Responsibilities:

  • Supervise and support quality 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.
  • 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.
  • Review the daily QA Lab planning schedule. Monitor adherence to quality standards, regulations, and best practices. Perform regular audits of QA processes.
  • 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.
  • 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 QA 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:

  • Must have a pharmacy, biomedical engineering, or biotechnology degree 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 (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.

Benefits:

This position offers a unique opportunity to work in a dynamic and challenging environment where you can apply your skills and experience to drive improvements and ensure the success of the Quality Assurance Department.

Application Process:

Please submit your CV/Resume detailing your experience and qualifications with the subject line 'Quality Assurance Manager'.

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