Quality Assurance

Tech4Life Enterprises Canada Inc; Karachi Division; On-site; PKR 900,000 - 1,500,000; Full time

Job summary

Tech4Life Enterprises Canada Inc is seeking a trained and detail-oriented Quality Assurance Officer to implement and maintain the Quality Management System in line with ISO 13485. The role includes audit readiness, controlled documentation, and cross-department coordination to ensure quality across the organization.

The ideal candidate will have formal ISO 13485 training, 2+ years in a regulated industry, and strong writing, communication, and organizational skills to drive continuous

Qualifications

• Formal ISO 13485 training is required and Internal Auditor or Lead Auditor certification preferred.
• 2+ years of relevant experience in medical devices, pharmaceuticals, healthcare, or a regulated industry.
• Strong technical writing, communication, training, analytical, and organizational skills.

Responsibilities

• Lead QMS implementation, maintenance, and continuous improvement to ISO 13485 and regulatory requirements.
• Plan and conduct internal audits; coordinate certification, surveillance, customer, and regulatory audits.
• Develop, review, and maintain Quality Manual, SOPs, work instructions, forms, records, and documentation.
• Coordinate staff training on ISO 13485, QMS, CAPA, audit, risk-management, and quality awareness.
• Manage CAPA, NCRs, deviations, root-cause investigations, and effectiveness verification.

Skills

Technical writing

Communication

Training

Analytical

Organizational skills

Education

Biomedical Engineering

Pharmaceutical Sciences

Quality Management

Life Sciences

Engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Tech4Life Enterprises is seeking a trained and detail-oriented Quality Assurance Officer to implement, maintain, and continuously improve the company’s Quality Management System. The role is responsible for end-to-end ISO 13485 compliance, staff training, audit readiness, controlled documentation, and coordination of quality activities across departments.

Requirements:

• Lead the implementation, maintenance, and continuous improvement of the QMS in accordance with ISO 13485 and applicable regulatory requirements.
• Conduct QMS gap assessments, prepare implementation plans, and ensure timely closure of identified compliance gaps.
• Develop, review, control, and maintain the Quality Manual, SOPs, work instructions, forms, records, and technical documentation.
• Prepare and deliver ISO 13485, QMS, SOP, CAPA, audit, risk-management, and quality-awareness training to employees.
• Maintain training plans, attendance records, competency records, and training-effectiveness evaluations.
• Plan and conduct internal audits; coordinate certification, surveillance, customer, and regulatory audits; and track findings to effective closure.
• Manage CAPA, NCR, deviations, root-cause investigations, corrective actions, and effectiveness verification.
• Support risk management, design controls, supplier qualification, purchasing controls, and product-quality documentation.
• Support complaint handling, post-market surveillance, vigilance reporting, product returns, and field actions where applicable.
• Coordinate management reviews, quality objectives, QMS performance indicators, compliance reports, and action tracking.
• Monitor changes in applicable standards and regulations and update the QMS and staff training accordingly.
• Ensure all quality records are complete, traceable, controlled, audit-ready, and retained in accordance with defined requirements.

Qualifications and Experience

Bachelor’s degree in Biomedical Engineering, Pharmaceutical Sciences, Quality Management, Life Sciences, Engineering, or a related discipline.

Formal training in ISO 13485 is required; Internal Auditor or Lead Auditor certification is preferred.

At least 2 years of relevant experience in medical devices, pharmaceuticals, healthcare, or another regulated industry.

Practical experience in QMS implementation, document control, staff training, audits, CAPA, NCR, and risk management.

Strong technical writing, communication, training, analytical, and organizational skills.

Proficiency in Microsoft Word, Excel, and PowerPoint.

Ability to work independently, coordinate cross-functional teams, and elevate quality risks to management.