Quality Assurance Lead: ISO 13485 & Process Improvement

BIO-RAD LABORATORIES (SINGAPORE) PTE LTD; Singapore; On-site; SGD 60,000 - 78,000; Full time

Benefits offered by this job

Medical plans

Insurance

Flexible benefits

Wellness programs

Learning and development opportunities

Job summary

Bio-Rad Laboratories (Singapore) Pte Ltd is seeking a Quality Control professional to drive non-conformance resolution, support QC testing, and collaborate with manufacturing and supplier quality teams to meet regulatory requirements. The role focuses on process validation, defect analysis, and KPI-driven improvements across the QC laboratory and production support areas.

The candidate should have a degree in chemistry or life sciences, 3+ years in regulated manufacturing QC, and hands-on

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/or ISO13485 requirements. Preferable lead auditor certified.

Responsibilities

• Initiate internal and supplier non-conformances review meetings to ensure timely disposition and closure of QNs.
• Proactively monitor QC test yield, collaborate with Engineering and Manufacturing to identify and implement improvements to manufacturing processes or QC test procedures.
• Attend Complaint Review meetings. Participate in failure analysis of Customer Returned Instrument to verify complaint and identify Product Quality improvement opportunities.
• Establish process Quality Control criteria and provide training to QC Technicians as needed.
• Monitor process, product quality and performance trend. Implement effective improvement initiatives to meet organization KPI targets.
• Manage QC laboratory activities to support production. Maintain a validated QC laboratory including equipment trouble shooting if required.
• Participate and review Site Process Validation activities to ensure Quality control adequacy.
• Generate weekly, monthly Quality performance reports for trend analysis and presentation in scheduled Management Review meeting.

Skills

Problem-solving

Interpersonal skills

Communication

Leadership

Self-motivated

Results-oriented

Education

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

Tools

SAP

Job description

Bio-Rad Laboratories (Singapore) Pte Ltd is seeking a Quality Control professional to drive non-conformance resolution, support QC testing, and collaborate with manufacturing and supplier quality teams to meet regulatory requirements. The role focuses on process validation, defect analysis, and KPI-driven improvements across the QC laboratory and production support areas.

The candidate should have a degree in chemistry or life sciences, 3+ years in regulated manufacturing QC, and hands-on