Quality Assurance Officer
Open Position
General Description:
About us:
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 escalate quality risks to management.
Job Type:
Permanent
Location: Karachi
Application Deadline: 31/08/2026
Reporting To: Management / QMS Lead
How to Apply:
Send your CV to hr@tech4lifeenterprises.com