Assistant Manager – Quality Assurance (QA), Surgical Instruments

Job description:

Job Purpose:

The Assistant Manager QA will oversee the implementation and maintenance of quality assurance processes at the Sialkot factory for surgical instruments. The role ensures compliance with ISO 13485, CE, MDR, and customer-specific requirements. The individual will monitor production quality, conduct inspections, manage audits, and coordinate with the Lahore QA Manager to achieve company quality goals.

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Key Responsibilities:

1. Quality Management System (QMS):

· Ensure adherence to ISO 13485, MDR, and customer-specific quality requirements.

· Assist in maintaining and improving the Quality Management System (QMS) documentation and implementation.

· Monitor and ensure compliance with SOPs across production and inspection processes.

2. Quality Control & Inspections:

· Supervise incoming, in-process, and final product inspections.

· Review and approve quality control reports and maintain traceability records.

· Address quality issues promptly and coordinate corrective actions with relevant teams.

3. CAPA & Complaint Handling:

· Support in investigating customer complaints and preparing detailed reports.

· Assist in implementing Corrective and Preventive Actions (CAPA) to avoid recurrence of issues.

· Ensure complaint records and CAPA are maintained according to regulatory standards.

4. Supplier & Process Audits:

· Assist in conducting supplier audits to ensure raw materials and components meet specifications.

· Perform internal process audits to identify non-conformities and areas for improvement.

· Support external regulatory and customer audits conducted at the Sialkot facility.

5. Training & Compliance:

· Provide training to production and QA staff on quality standards, inspection methods, and documentation.

· Ensure awareness of cleanroom protocols, sterility assurance, and proper handling of surgical instruments.

6. Coordination & Reporting:

· Act as the liaison between the Sialkot factory and Lahore QA Manager for quality-related matters.

· Prepare weekly quality reports (inspection status, non-conformities, complaints, etc.) for Lahore management.

· Coordinate closely with production, packaging, and logistics teams to ensure quality at every stage.

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Qualifications & Experience:

· Bachelor’s degree in Quality Assurance, Industrial/Mechanical Engineering, or a related field.

· Minimum 3–5 years of experience in surgical instrument manufacturing or medical device QA.

· Knowledge of ISO 13485, MDR, CE marking, and regulatory audits.

· Experience with CAPA, non-conformance handling, and supplier audits.

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Skills Required:

· Strong knowledge of quality control tools and techniques (AQL, sampling plans, etc.).

· Proficiency in documentation, reporting, and audit handling.

· Good communication and interpersonal skills to coordinate with cross-functional teams.

· Analytical and problem-solving abilities to identify root causes and implement corrective actions.

· Proficiency with MS Office and ERP systems for QA reporting.

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Working Conditions:

· Based at the Sialkot manufacturing facility.

· Requires coordination with Lahore QA team and periodic travel between locations.

· Full-time role; flexibility to work extended hours during audits or urgent QA activities.

Job Type: Full-time

Pay: Rs45,000.00 - Rs50,000.00 per month

Work Location: In person