Sehat Medical Devices (Pvt.) Ltd., located in Sundar Industrial Estate, Lahore, is seeking a qualified, motivated, and detail-oriented professional to join its Quality Assurance & Compliance Team as a QA & Compliance Officer. This role is ideal for individuals passionate about maintaining high standards in quality management and regulatory compliance within the medical device and healthcare manufacturing sectors. The successful candidate will play a vital role in supporting the company’s commitment to quality, safety, and continuous improvement.
Key Responsibilities
- Support the implementation and ongoing maintenance of the Quality Management System (QMS) to ensure alignment with industry standards.
- Ensure compliance with all relevant quality, regulatory, GMP, and medical device requirements.
- Prepare, review, update, and maintain Standard Operating Procedures (SOPs), specifications, forms, reports, and quality records.
- Assist in managing Corrective and Preventive Actions (CAPA), change control processes, deviations, non-conformance issues, and complaint investigations.
- Provide support during internal, customer, and regulatory audits to ensure readiness and compliance.
- Contribute to risk assessment, validation, verification, and continuous improvement initiatives.
- Review and maintain documentation related to manufacturing, inspection, testing, and overall quality assurance.
- Support microbiology-related activities including microbiological testing, environmental monitoring, contamination control, and laboratory documentation.
- Assist with medical device-specific tasks such as technical documentation, product quality assurance, risk management, validation, and regulatory compliance.
- Coordinate effectively with cross-functional teams including Production, Quality Control (QC), Research & Development (R&D), Engineering, and Regulatory Affairs.
- Ensure proper documentation practices, traceability, data integrity, and strict adherence to approved procedures.
- Identify quality issues proactively and support timely implementation of corrective and preventive actions.
Required Qualifications
- A relevant degree in Pharm-D, Microbiology, or Biomedical Engineering.
- Open to both fresh graduates and experienced candidates.
- Basic knowledge of Quality Management Systems (QMS), Good Manufacturing Practices (GMP), Quality Assurance/Quality Control (QA/QC), documentation standards, compliance, and auditing processes is advantageous.
- Strong analytical and problem-solving abilities.
- Excellent attention to detail.
- Good communication skills and ability to work collaboratively within a team.
- Proficiency in MS Office applications and documentation management.
Preferred Qualifications and Benefits
- Experience in the medical device, pharmaceutical, healthcare, or regulated manufacturing industries will be highly preferred.
- Opportunity to work in a dynamic and growing company focused on quality and innovation.
- Hands-on exposure to regulatory compliance and quality assurance processes in a regulated environment.
- Work location is in-person at the Sundar Industrial Estate facility in Lahore, providing direct engagement with production and quality teams.
This position offers a valuable opportunity for candidates looking to develop their careers in quality assurance and compliance within the medical device sector. If you meet the qualifications and are eager to contribute to a reputable organization committed to quality and compliance, you are encouraged to apply.
Please note that applications should be submitted through the official company channels as specified in the recruitment process.