Quality Control Specialist I: Regulated Lab Focus

Bio-Rad Laboratories, Inc.; Singapore; On-site; SGD 40,000 - 67,000; Full time

Job summary

Bio-Rad Laboratories, Inc. in Bedok, Singapore, is seeking a Quality Control Spec I to drive resolution of product quality issues and support QC testing and reagent management to meet ISO 13485 and regulatory requirements.

You will collaborate with production, engineering and supplier quality teams, monitor QC data, establish QC criteria, and train QC technicians. Regular quality performance reports will be generated for Management Review meetings.

Qualifications

• Bachelor's degree in Chemistry, Bio-Chemistry or Life Science.
• Min 3 years of manufacturing quality control in a regulated environment with exposure to QC laboratory process is preferred.
• Experience with ERP systems a plus, SAP preferred.
• Knowledge of MDSAP and ISO13485 requirements. Preferable lead auditor certified.
• Knowledge of Good Laboratory Practice (GLP) and bio-hazard materials handling.

Responsibilities

• Initiate internal and/or supplier non-conformances review meetings to ensure timely disposition and closure of QNs.
• Proactively monitor QC test yield and collaborate with Engineering and Manufacturing to identify and implement improvements to manufacturing processes or QC test procedures.
• Attend Complaint Review meetings and participate in failure analysis of Customer Returned Instrument to identify product quality improvement opportunities.
• Establish QC criteria and provide training to QC Technicians as needed.
• Monitor process, product quality and performance trends; implement improvements to meet KPI targets.
• Manage QC laboratory activities to support production and maintain a validated QC laboratory.

Skills

Statistical tools

Lean Six Sigma

Problem solving

Communication

Leadership

Education

Bachelor's degree in Chemistry or Life Science

Tools

SAP

Job description

Bio-Rad Laboratories, Inc. in Bedok, Singapore, is seeking a Quality Control Spec I to drive resolution of product quality issues and support QC testing and reagent management to meet ISO 13485 and regulatory requirements.

You will collaborate with production, engineering and supplier quality teams, monitor QC data, establish QC criteria, and train QC technicians. Regular quality performance reports will be generated for Management Review meetings.