QC Manager

7 hours ago

Lahore, Punjab, Pakistan Sehat Medical Devices Pvt Ltd Full time $90,000 - $120,000 per year

QC Manager

Location:
Sundar Industrial Estate, Lahore, Pakistan

Department:
Quality Control

Position Overview

The QC Manager will be responsible for overseeing all quality control operations at Sehat Medical Devices Pvt Ltd (SMD), ensuring products meet international quality standards, regulatory requirements, and customer specifications. This role requires deep technical expertise in medical device manufacturing, particularly syringes, infusion sets, and other disposables, as well as leadership skills to manage a multidisciplinary QC team.

Key Responsibilities

Quality Control Operations

  • 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 SMD's validated protocols.
  • Manage product traceability systems, including
    batch number verification, retention samples, and documentation
    .

Compliance & Regulatory

  • Ensure full compliance with
    DRAP regulations, ISO standards, and international customer requirements
    .
  • Prepare and maintain QC records for regulatory audits, customer 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.

Lab Management

  • Supervise QC 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 QC instruments.
  • Establish lab safety protocols and training for staff.

Team Leadership

  • Manage, train, and mentor the QC team, including inspectors, lab technicians, and microbiologists.
  • Set departmental KPIs and monitor performance against targets.
  • Foster a culture of continuous improvement and root cause problem-solving.

Investigation and Continuous Improvement

  • Lead product non-conformance investigations, CAPA (Corrective and Preventive Actions), and deviation handling.
  • Work closely with Production, QA, and R&D teams to resolve quality issues.
  • Implement statistical process control (SPC) and other data-driven quality improvement tools.

  • Recommend process changes to reduce defects, improve yields, and ensure zero-compromise on product safety.

  • QUALIFICATIONS

  • Bachelor's or Master's degree in Biomedical Engineering, Pharmacy, Bio Technology etc
  • 8+ years of experience in QC, preferably in medical device manufacturing.
  • In-depth knowledge of ISO 13485, ISO 10993, ISO 7886-1, ISO 7864, and relevant product standards.
  • Experience with GMP, regulatory audits, and third-party certifications.
  • Strong analytical skills with hands-on experience in laboratory testing and inspection methods.
  • Proficiency in MS Office, ERP/Quality Management Systems

Interested candidates are encouraged to apply at or through the easy apply button on linkedin

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