QC Operations Leader — Quality & Compliance

Biosensors Interventional Technologies Pte Ltd; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

Biosensors Interventional Technologies Pte Ltd in Singapore is seeking a seasoned QC/QA leader to oversee IQC, IPQC, LRQC and OQC for LMP, CM/OEM and TPP products, ensuring readiness for audits and regulatory compliance.

You will align resources, manage a lab team, and drive continuous improvement using SPC, AQL and GMP standards while maintaining calibration records and timely batch releases.

This role requires a Bachelor in science or engineering and 3–5 years of QC/QA experience.

Qualifications

• Bachelor degree in Science or Engineering or equivalent.
• 3-5 years of QC/QA experience with understanding of measurement instruments.
• Knowledge of MDD/MDR, ISO 13485.
• Experience with cGMP/GDP/GLP requirements.
• Knowledge of SPC and quality management/analysis/improvement tools.
• Leadership experience and people management skills.

Responsibilities

• Provide overall supervision to IQC, IPQC, LRQC and OQC operations.
• Establish training plan for new joiners and maintain training competency.
• Oversee inspectors/lab staff to support on-time delivery of quality products.
• Work out QC capacity plan and resource requirements to meet demand.
• Maintain calibration/verification of measurement equipment/tools.
• Apply AQL and SPC and prepare quality reports.
• Review test reports and ensure timely lot release of materials and goods.
• Ensure compliance with QMS, cGMP, GDP, GLP; support audits.

Skills

Leadership & people management

Analytical skills

Problem solving

Communication skills

Integrity & ethics

Ability to work under pressure

Education

Bachelor degree in Science or Engineering

Tools

Calibration & verification equipment

Job description

Biosensors Interventional Technologies Pte Ltd in Singapore is seeking a seasoned QC/QA leader to oversee IQC, IPQC, LRQC and OQC for LMP, CM/OEM and TPP products, ensuring readiness for audits and regulatory compliance.

You will align resources, manage a lab team, and drive continuous improvement using SPC, AQL and GMP standards while maintaining calibration records and timely batch releases.

This role requires a Bachelor in science or engineering and 3–5 years of QC/QA experience.