Quality Control & Process Improvement Specialist

BIO-RAD LABORATORIES (SINGAPORE) PTE LTD; Singapore; On-site; SGD 67,000 - 100,000; Full time

Job summary

Bio-Rad Laboratories (Singapore) PTE LTD is seeking a Manufacturing Quality professional to drive resolution of product quality issues through collaboration with production, manufacturing engineering and supplier quality teams.

You will monitor process data, initiate improvements to meet ISO 13485 (MDSAP) and regulatory requirements, and support QC Instrument Test and reagent management to meet delivery commitments.

Qualifications

• Bachelor's degree in Chemistry, Bio-Chemistry or Life Science.
• Min 3 years of manufacturing quality control experience in a regulated environment.
• Experience with Process Validation and Non-conforming processes.
• Experience with Customer Complaint investigations.
• Knowledge of MDSAP and ISO13485; lead auditor certification preferred.
• GLP knowledge; handling and disposal of bio-hazard materials.
• Hands-on use of statistical tools; Lean Six Sigma Green Belt preferred.
• Strong problem-solving, interpersonal, communication and leadership skills.

Responsibilities

• Initiate internal and/or supplier non-conformances review meetings to ensure timely disposition and closure of QNs.
• Proactively monitor QC test yield; collaborate with Engineering and Manufacturing to improve processes or QC procedures.
• Attend Complaint Review meetings; perform failure analysis of Customer Returned Instruments to verify complaints and identify improvements.
• Establish QC criteria and provide training to QC Technicians as needed.
• Monitor process, product quality and performance trends; drive KPI-driven improvements.
• Manage QC laboratory activities to support production; maintain a validated QC lab and troubleshoot equipment.
• Participate in Site Process Validation activities to ensure quality control adequacy.
• Generate weekly and monthly quality performance reports for trend analysis and management review.

Skills

Problem solving

Interpersonal skills

Communication

Leadership

Statistical tools

Lean Six Sigma

Education

Bachelor's degree in Chemistry, Bio-Chemistry or Life Science

Lead Auditor Certification

Tools

SAP

Job description

Bio-Rad Laboratories (Singapore) PTE LTD is seeking a Manufacturing Quality professional to drive resolution of product quality issues through collaboration with production, manufacturing engineering and supplier quality teams.

You will monitor process data, initiate improvements to meet ISO 13485 (MDSAP) and regulatory requirements, and support QC Instrument Test and reagent management to meet delivery commitments.