QUALITY ASSURANCE TECHNICIAN

We are seeking a detail-oriented Quality Assurance Technician to support TSSB’s Quality Assurance Department in maintaining product and process quality standards.

Quality Assurance Technician will assist with inspections, testing, documentation, and data collection, working closely with the Quality Team to ensure compliance with ISO 13485 and cleanroom requirements.

Candidates should thrive in a fast-paced, regulated environment, demonstrate strong observational and analytical skills, and take pride in maintaining the highest standards of product quality, safety, and reliability.

Responsibilities

●      Maintain awareness of the company’s Quality Policy and ensure compliance in all production and product handling activities.

●      Verify that in-line equipment used on the production line is properly calibrated and well maintained; report any issues or problems to supervisors in a timely manner.

●      Assist in tracking and scheduling the calibration of inspection, measuring, and test equipment, maintain accurate calibration records to ensure compliance with established calibration intervals and quality system requirements, and verify calibration results/reports received from external calibration service providers.

●      Plan, execute, and oversee inspection and testing of products to verify conformance with specifications or customer requirements.

●      Verify and confirm parts or partially completed products associated with test failures, and update relevant test parameters, specifications, and equipment settings to align with the latest client engineering requirements. Ensure all associated test documentation/work instruction/SOP is accurately revised, reviewed, and maintained under document control to support traceability and regulatory compliance.

●      Identify and segregate non -conforming materials; support Nonconformance and CAPA activities in accordance with the company’s Quality Management System.

●      Observe manufacturing processes for deviations from established procedures and specifications, reporting any anomalies to supervisors promptly for further investigation and corrective action.

●      Assist in on-the-job training (OJT) for QC Inspectors to improve skills and quality awareness.

●      Liaison with customers on various matters such as complaints, technical enquiries, sampling plans, specification, quality issues.

●      Collect, record, and maintain accurate inspection data, test results, and quality records in the QMS system, and perform data analysis to identify trends, support decision-making, and drive continuous improvement, providing input for management review meetings.

●      Collaborate with Manufacturing and Engineering teams to support root-cause analysis and continuous improvement initiatives, resolve quality issues, and ensure timely product release while maintaining compliance with quality system requirements.

●      Develop and update inspection plans, control plans, work instructions and SOPs.

●      Manage and control golden samples per SOP; review and update golden sample revisions in response to product changes or customer requirements.

●      Conduct Material Review Board (MRB) meetings with cross-functional team members to review non-conforming materials and determine appropriate disposition ensuring timely resolution and proper documentation in accordance with quality system requirements.

●      Review and verify the accuracy and completeness of all batch traveler documentation prior to final product release to the client, ensuring compliance with quality standards and regulatory requirements.

●      Manage the complete sterilization release lifecycle, encompassing pre-dispatch verification of lot traceability and documentation accuracy, and post-receipt validation of sterilization efficacy, ensuring all products meet stringent release criteria prior to client shipment.

●      Maintain organized, audit-ready documentation in accordance with document control and record retention requirements.

●      Participate in internal audits and support external audits (ISO 13485, Customer Audit, regulatory audit as applicable).

●      Perform any tasks which are assigned by superiors.

Requirements

●      Diploma / Bachelor’s degree (or equivalent) in engineering or related field or

●      Prior experience in manufacturing or production environments is required; experience working in a cleanroom within the medical industry is an advantage.

●      Working knowledge of quality assurance terminology, methods, and tools.

●      Preferably possesses ISO audit experience/skills, along with a strong understanding of quality management systems such as ISO 13485 and cleanroom standards.

●      Excellent analytical, problem-solving, and decision-making skills.

Demonstrate strong attention to detail and commitment to quality while working independently or collaboratively in a fast-paced production environment.