Assistant QA Officer

At Alframed, we are committed to enhancing patient care through the design and manufacturing of high-quality surgical instruments. Our reputation for innovation, precision, and reliability has established us as a trusted name in the industry. We are currently seeking dedicated and detail-oriented Assistant QA Officers to join our Quality Assurance team and contribute to our mission of delivering excellence in every product we create.

Position Overview:

As an Assistant QA Officer, you will play a crucial role in ensuring the quality, compliance and documentation of our surgical instruments. You will support the Quality Assurance team in implementing and monitoring quality control procedures, conducting inspections, and maintaining rigorous standards and documentation to meet regulatory requirements and customer expectations.

Key Responsibilities:

Maintain and control quality system documentation related to cGMP, ISO 9001 and ISO 13485:2003.
Execute quality management related different tasks / assignments / projects assigned by Manager QA within target dates.
Maintain quality management system in the production facility.
Maintain visits in production area to ensure that each process is conducted and followed by workers in compliance with established procedures.
Manage internal audit program and present audit results to Manager QA.
Ensure that quality procedures and work instructions in place are understood and followed.
Monitor that established traceability system is maintained at each production stage.
Supervise that quality management system is properly understood and implemented at all levels in the facility.
Ensure that device history record of each production lot is developed and retained in compliance with its relevant device master record.
Work closely with internal departments, including Quality Complaints, Product Development, and Regulatory Affairs, to address and resolve complaints. Collaborate with these teams to identify root causes and implement corrective actions.
Supervise and monitor equipment maintenance is performed according to requirements and schedules.
Maintain internal and external calibration record updated and ensure that calibration of equipment is performed according to schedule.
Maintain record of fire extinguishers installed in the facility and ensure that fire extinguishers are refilled before expiry date.
Maintain and conduct trainings program according to schedule.
Report to Manager QA on the performance of quality management system including needs for improvements.

Qualifications:

Bachelor’s degree in Engineering, Quality Assurance, or a related field preferred.
Prior experience in quality assurance or quality control, particularly in a Surgical manufacturing environment, is an advantage.
Strong understanding of quality control processes, quality documentation, regulatory standards (such as ISO, FDA), and testing methodologies.
Excellent attention to detail and analytical skills.
Strong communication skills and the ability to work effectively in a team-oriented environment.
Proficiency in using Microsoft Office, quality control tools and software ERP.

Why Join Us?

Be part of a dynamic and innovative company dedicated to making a difference in healthcare industry.
Opportunity for professional growth and development within a leading surgical instruments manufacturer.
Competitive salary and benefits package.
Company accommodation and food shall be provided.
Company
A collaborative and supportive work environment.