Senior Quality Assurance Specialist

3 days ago

Lahore, Punjab, Pakistan beBeeQualityControl Full time 2,000,000 - 3,000,000
Job Overview

The Quality Control Manager is responsible for leading all quality control operations, ensuring products meet international quality standards and customer specifications.

  • Lead all QC activities from raw material inspection to final product release.
  • Implement and maintain quality control procedures in compliance with ISO 13485, ISO 10993, ISO 9001, GMP, WHO PQ and DRAP Medical Device Rules 2017.
  • Ensure inspection and testing are carried out at all stages—incoming, in-process, and final—according to ISO 7886-1, ISO 8536, ISO 7864, and other relevant standards.
  • Oversee microbiological, chemical, and mechanical testing in accordance with the company's validated protocols.
  • Manage product traceability systems, including batch number verification, retention samples, and documentation.
  • Ensure full compliance with regulatory requirements and international customer expectations.
  • Prepare and maintain QC records for audits, inspections, and internal reviews.
  • Support certification processes for ISO 13485 Notified Body audit, WHO Prequalification, CE Marking, and FDA 510(k).
  • Liaise with regulatory bodies for inspections, queries, and product approvals.
  • Supervise laboratory operations, ensuring calibration and maintenance of equipment such as Universal Testing Machines, Leak Testers, UV-Vis spectrophotometers, GC, AAS, and microbiology lab instruments.
  • Oversee procurement and qualification of new laboratory equipment.
  • Establish lab safety protocols and training for staff.
  • Manage, train, and mentor the quality control team.
  • Set departmental key performance indicators (KPIs) and monitor performance against targets.
  • Lead product non-conformance investigations, CAPA, and deviation handling.
  • Work closely with Production, QA, and R&D teams to resolve quality issues.
  • Implement statistical process control (SPC) and data-driven quality improvement tools.

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