Senior QC Operations Lead - Quality & Compliance

biosensors interventional technologies pte. ltd.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

biosensors interventional technologies pte. ltd. in Singapore seeks a capable QC leader to oversee IQC, IPQC, LRQC and OQC operations. You will manage the QC team, ensure adherence to ISO13485, MDR, GMP standards and drive continuous improvement across testing and release processes.

You will calibrate equipment, maintain training programs and coordinate with cross-functional teams to ensure timely, high-quality product release.

Qualifications

• Bachelor degree in Science or Engineering or equivalent.
• 3–5 years of experience in QC/QA with instrument knowledge.
• Knowledge of MDD/MDR and ISO 13485.
• Risk management knowledge (ISO 14971) is a plus.
• Experience with cGMP/GDP/GLP requirements.
• Knowledge of SPC and quality tools.
• Leadership and people management skills.
• Excellent interpersonal and communication skills.
• Ability to solve practical problems with limited standardization.
• High integrity and ability to work under stress.

Responsibilities

• Provide overall supervision to QC operations (IQC, IPQC, LRQC, OQC).
• Establish training plan and competency for new joiners and existing staff.
• Oversee inspectors and lab staff for on-time delivery of quality product.
• Work out QC capacity plan to meet sales demands.
• Maintain validity/calibration/verification of measurement equipment.
• Apply AQL and SPC; analyze data and trends.
• Review test reports and lot release forms for timely release.
• Ensure compliance with QMS, cGMP, 5S and audit readiness.
• Ensure health and safety in QC operations.

Skills

Leadership

People management

Interpersonal communication

Analytical thinking

Problem solving

Working under pressure

Education

Bachelor's degree in Science or Engineering

Job description

biosensors interventional technologies pte. ltd. in Singapore seeks a capable QC leader to oversee IQC, IPQC, LRQC and OQC operations. You will manage the QC team, ensure adherence to ISO13485, MDR, GMP standards and drive continuous improvement across testing and release processes.

You will calibrate equipment, maintain training programs and coordinate with cross-functional teams to ensure timely, high-quality product release.