Assistant Manager – Quality Assurance (QA), Surgical Instruments

The Assistant Manager QA will play a critical role in overseeing the quality assurance processes at the Sialkot factory, which specializes in surgical instruments. This position ensures full compliance with ISO 13485, CE, MDR, and customer-specific requirements. The individual will be responsible for monitoring production quality, conducting inspections, managing audits, and working closely with the Lahore QA Manager to achieve the company’s quality objectives.

Key Responsibilities

Quality Management System (QMS):
Ensure strict adherence to ISO 13485, MDR, and customer-specific quality standards. Assist in maintaining and improving the Quality Management System documentation and its effective implementation. Monitor compliance with Standard Operating Procedures (SOPs) throughout production and inspection activities.

Quality Control & Inspections:
Oversee inspections of incoming materials, in-process production, and final products. Review and approve quality control reports while maintaining thorough traceability records. Address quality issues promptly and coordinate corrective actions with relevant departments.

CAPA & Complaint Handling:
Support investigations into customer complaints by preparing detailed reports. Assist in the implementation of Corrective and Preventive Actions (CAPA) to prevent recurrence of issues. Ensure complaint records and CAPA documentation meet regulatory standards.

Supplier & Process Audits:
Assist in conducting supplier audits to verify that raw materials and components meet required specifications. Perform internal process audits to identify non-conformities and recommend improvements. Support external regulatory and customer audits at the Sialkot facility.

Training & Compliance:
Provide training to production and QA staff on quality standards, inspection methods, and documentation requirements. Promote awareness and compliance with cleanroom protocols, sterility assurance, and proper handling of surgical instruments.

Coordination & Reporting:
Act as the liaison between the Sialkot factory and the Lahore QA Manager for all quality-related matters. Prepare weekly quality reports detailing inspection status, non-conformities, and complaints for Lahore management. Collaborate closely with production, packaging, and logistics teams to maintain quality throughout all stages.

Required Qualifications

- Bachelor’s degree in Quality Assurance, Industrial or Mechanical Engineering, or a related discipline.
- 3 to 5 years of experience in surgical instrument manufacturing or medical device quality assurance.
- Strong knowledge of ISO 13485, MDR, CE marking, and regulatory audit processes.
- Experience in CAPA management, non-conformance handling, and supplier audits.

Skills Required

- Proficiency in quality control tools and techniques such as AQL and sampling plans.
- Strong skills in documentation, reporting, and audit management.
- Excellent communication and interpersonal abilities for effective coordination with cross-functional teams.
- Analytical and problem-solving skills to identify root causes and implement corrective actions.
- Proficient in MS Office and ERP systems for QA reporting.

Preferred Qualifications and Benefits

The position is based at the Sialkot manufacturing facility with regular coordination and occasional travel to Lahore. It is a full-time role requiring flexibility to work extended hours during audits or urgent QA activities. Accommodation and food allowance are provided for candidates relocating from outside Sialkot. The monthly salary range is Rs70,000 to Rs80,000. This role offers an excellent opportunity to contribute to high-quality surgical instrument manufacturing within a regulated environment, supporting continuous improvement and compliance excellence.