Quality Control Analyst I — ISO 13485 Focus

Bio-Rad Laboratories (Singapore) Pte Ltd - MFG; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Bio-Rad Laboratories (Singapore) Pte Ltd - MFG is seeking a Quality Assurance professional to drive product quality improvements, collaborate with production, manufacturing engineering and supplier quality teams, and ensure compliance with ISO 13485 and regulatory requirements.

You will monitor process data, support QC Instrument Test on reagent management, and update procedures to meet delivery commitments.

Qualifications

• Min 3 years of manufacturing quality control in a regulated environment with exposure to QC laboratory process.
• Experience in Process Validation, Non-conforming Process, Customer Complaint investigation.
• Knowledge of MDSAP and ISO13485 requirements; lead auditor certification preferred.
• Knowledge of Good Laboratory Practice and handling/disposal of bio-hazard materials.
• Statistical tools experience; Lean/Six Sigma Green Belt preferred.
• Self-motivated, result oriented with minimal supervision.

Responsibilities

• Drive resolution for product quality issues by collaborating with production, manufacturing engineering and supplier quality teams.
• Monitor process data and initiate improvements to meet ISO 13485 (MDSAP) and regulatory requirements.
• Support QC Instrument Test on reagent management and procedural updates to meet delivery commitments.
• Initiate supplier/non-conformance review meetings and ensure timely disposition and closure of QNs.
• Monitor QC test yield and implement improvements to manufacturing processes or QC test procedures.
• Attend Complaint Review meetings and participate in failure analysis of Customer Returned Instrument.
• Establish QC criteria and provide training to QC Technicians as needed.
• Monitor performance trends and implement improvement initiatives to meet KPI targets.
• Manage the QC laboratory activities and maintain a validated QC laboratory; troubleshoot equipment.
• Participate in Site Process Validation activities to ensure Quality control adequacy.
• Generate weekly/monthly Quality performance reports for management review.

Skills

Problem-solving

Interpersonal skills

Communication

Leadership

Education

Bachelor’s Degree in Chemistry, Bio-Chemistry or Life Science.

Tools

SAP

ERP systems

Job description

Bio-Rad Laboratories (Singapore) Pte Ltd - MFG is seeking a Quality Assurance professional to drive product quality improvements, collaborate with production, manufacturing engineering and supplier quality teams, and ensure compliance with ISO 13485 and regulatory requirements.

You will monitor process data, support QC Instrument Test on reagent management, and update procedures to meet delivery commitments.