Quality Engineer [EL]

WECRUIT PTE. LTD.; Singapore; On-site; SGD 60,000 - 110,000; Full time

Job summary

WECRUIT PTE. LTD. in Singapore is seeking a Senior Quality Engineer to drive product and process quality through structured problem-solving, root-cause analysis, CAPA, and process validation.

The role works with Production and cross-functional teams to sustain conformity, improve process capability, monitor quality trends, support audits, and ensure compliance with ISO 14971 and applicable quality systems. You will report on quality performance and contribute to continuous improvement

Qualifications

• Lead investigations into product and process non-conformances using structured problem-solving methodologies.
• Drive corrective and preventive action (CAPA) activities and ensure actions are implemented effectively and sustainably.
• Support Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of equipment and processes.
• Monitor process capability, stability, production yield and defect performance.
• Assist in internal and regulatory audits and ensure compliance with quality management systems.

Responsibilities

• Root-Cause Analysis and CAPA Management: lead investigations into non-conformances using 5 Whys, Fishbone, FMEA and other tools.
• Process Validation and Quality Assurance: support IQ/OQ/PQ for equipment and processes; investigate failures and maintain conformity.
• Process Quality and Performance Improvement: monitor capability and defects; apply SPC, MSA and Kaizen for improvement.
• Quality Compliance and Risk Management: assist audits and ensure ISO 14971 compliance; identify and mitigate risks.
• Quality Reporting and Documentation: prepare metrics, trends and reports; maintain records and present findings.

Job description

The Senior Quality Engineer is responsible for driving product and process quality through structured problem-solving, root-cause analysis, corrective and preventive actions (CAPA), process validation and continuous improvement initiatives. The role works closely with Production and cross-functional teams to maintain product conformity, improve process capability and ensure compliance with applicable quality and regulatory requirements.

Key Responsibilities

1. Root-Cause Analysis and CAPA Management
   • Lead investigations into product and process non-conformances using structured problem-solving methodologies, including 5 Whys, Fishbone Analysis, FMEA and other root-cause analysis tools.
   • Drive corrective and preventive action (CAPA) activities and ensure actions are implemented effectively and sustainably.
   • Work with relevant departments to identify recurring quality issues and prevent their recurrence.
   • Monitor CAPA effectiveness and ensure timely closure of corrective actions.
2. Process Validation and Quality Assurance
   • Support Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of equipment, manufacturing processes and test methods.
   • Work closely with Production to investigate process failures, analyse quality data and maintain product conformity.
   • Review validation results and support the implementation of appropriate process controls.
   • Ensure manufacturing processes consistently meet established quality requirements.
3. Process Quality and Performance Improvement
   • Monitor and improve process capability, stability, production yield and defect performance.
   • Apply quality engineering tools, including Statistical Process Control (SPC), Measurement System Analysis (MSA) and Failure Mode and Effects Analysis (FMEA).
   • Analyse quality trends and identify opportunities to reduce defects and improve manufacturing performance.
   • Drive continuous improvement, Lean and Kaizen initiatives to enhance process efficiency and product quality.
4. Quality Compliance and Risk Management
   • Support internal, customer and regulatory audits.
   • Assist in ensuring compliance with applicable quality management systems and regulatory requirements.
   • Support product and process risk management activities in accordance with ISO 14971.
   • Identify potential quality risks and recommend appropriate mitigation measures.
5. Quality Reporting and Documentation
   • Prepare quality performance metrics, trend analyses and management reports.
   • Monitor key quality indicators and provide updates on quality improvement activities.
   • Maintain accurate records of investigations, CAPA, validation activities and quality documentation.
   • Present quality findings and improvement recommendations to relevant stakeholders.

EA License No: 20C0270

Wecruit Pte Ltd