Quality System Specialist I

Responsibilities

• Support the implementation and maintenance of the Quality Management System (QMS) in alignment with ISO 9001, ISO 13485, and IVDR requirements.
• Maintain and improve the QMS to meet regulatory standards and business objectives for the Singapore Distribution Centre.
• Identify nonconformances, perform root cause analysis, and issue Corrective Action Reports (CAPA).
• Oversee Quality Notifications (QNs), including plant-to-plant issues, global shipment holds, and scrap orders via SAP.
• Execute final quality checks for IVDR and non-IVDR product shipments to ensure correct labelling and compliance.
• Inspect returned or nonconforming products and provide disposition decisions.
• Ensure cold chain integrity by assessing data loggers in shipments and escalating temperature deviations.
• Coordinate labelling verification and approvals with Regulatory Affairs and internal stakeholders.
• Perform traceability and batch verification checks to ensure alignment between ERP data and physical packaging.
• Support internal and external audits by preparing documentation and providing process walkthroughs.
• Maintain regulatory standards libraries and update SOPs, WIs, and forms.

Requirements

• Diploma or Bachelor’s degree in Biology, Chemistry, Medical Technology, or a related field.
• 1-2 years of related experience or an equivalent combination of education and experience.
• Working knowledge of Quality Assurance policies, practices, and procedures.
• Strong analytical, problem-solving, and critical thinking skills.
• Proficient computer skills and ability to communicate effectively with stakeholders.
• Ability to work tactfully and build cooperative professional relationships.

Benefits

• Comprehensive medical plans and insurance.
• Wellness programs.
• Extensive learning and development opportunities.
• A collaborative and inclusive work environment.

About the Company

Bio-Rad is a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. For 70 years, we have focused on advancing the discovery process and transforming the fields of science and healthcare to help people live longer, healthier lives.