Manager of QA/QC – Medical Devices Manufacturing (DRAP Compliance)

Position Overview

The Manager of Quality Control (QC) & Quality Assurance (QA) leads the factory’s quality function for medical devices and disposables (bandages, masks, medical tapes, and related products). This role ensures full compliance with Drug Regulatory Authority of Pakistan (DRAP) Medical Device Rules 2017, Good Manufacturing Practices for Medical Devices (GDPMD), and ISO 13485 Quality Management Systems. The position oversees quality testing, assurance systems, audits, regulatory compliance, and continuous improvement of product quality and safety.

Key Responsibilities

1. Regulatory & Compliance Oversight:

• Ensure all quality systems comply with DRAP Medical Device Rules 2017 and ISO 13485 requirements.
• Maintain valid DRAP certifications, licenses, and product registrations for all manufactured devices.
• Prepare and manage documentation required for DRAP audits, GMP/GDPMD inspections, and ISO audits.
• Liaise with regulatory bodies (DRAP, MoH) during inspections, ensuring timely responses to observations.

2. Quality Assurance (QA):

• Develop, implement, and maintain SOPs for all production and quality processes.
• Oversee validation and qualification activities (equipment, processes, and cleanrooms).
• Ensure all raw materials, in-process checks, and finished goods comply with quality and regulatory requirements.
• Lead Corrective and Preventive Actions (CAPA) for deviations and non-conformities.
• Ensure proper implementation of Document Control and Change Control systems.

3. Quality Control (QC):

• Oversee laboratory and in-process QC testing for raw materials, intermediates, and finished products.
• Monitor and report number of quality issues per month and ensure corrective actions.
• Validate and maintain testing methods for accuracy, reliability, and compliance with device standards.
• Ensure calibration and maintenance of laboratory instruments.
• Review and approve Certificates of Analysis (CoA) and release of finished goods.

4. Risk Management & Safety:

• Implement risk-based quality management in line with ISO 14971 (Risk Management for Medical Devices).
• Ensure hygienic, contamination-free production environments through audits and inspections.
• Work with the Operations Manager to maintain a Zero Total Recordable Incident Rate (TRIR) and maximize safe man-hours.

5. Audits & Inspections:

• Lead internal quality audits to ensure compliance with GDPMD, ISO 13485, and DRAP requirements.
• Coordinate management reviews and ensure continuous improvement of the QMS.
• Lead preparation for DRAP and ISO surveillance audits, ensuring audit readiness across departments.

6. Team Leadership & Training:

• Manage and mentor QC/QA staff to build strong technical and compliance capabilities.
• Conduct regular training sessions for production and QC/QA teams on GDPMD, GMP, ISO 13485, hygiene, and quality standards.
• Foster a culture of quality, accountability, and regulatory compliance across the organization.

7. KPI Monitoring & Reporting:

• Track and report the following KPIs regularly:
• Number of quality issues per month in QC checks.
• CAPA closure rate and lead time.
• Audit observations vs. compliance closures.
• Planned vs. Actual product release timelines.
• % of batches released without deviation.
• Material rejection rate ≤1% (in line with wastage targets).
• Submit quality performance reports to senior management and regulatory bodies where required.

Education & Experience Requirements:

• Bachelor’s or Master’s in Pharmacy, Microbiology, Biomedical Engineering, or related field.
• Minimum 8–12 years’ experience in QC/QA within medical devices or pharmaceutical manufacturing, including at least 3 years in a leadership role.
• In-depth knowledge of DRAP Medical Device Rules 2017, GDPMD, ISO 13485, and ISO 14971.
• Strong background in laboratory management, audits, and regulatory compliance.

Key Skills & Competencies:

• Expertise in quality systems (QMS), validation, and compliance.
• Strong leadership in audit handling (internal & external).
• Proficiency in CAPA, deviation handling, and root cause analysis.
• Excellent documentation, reporting, and regulatory communication skills.
• Analytical and problem-solving skills with a focus on continuous improvement.

Job Type: Full-time

Pay: Rs125,000.00 - Rs175,000.00 per month

Work Location: In person