Quality Systems Engineer - ISO 13485/9001 & Audits

C & W ELECTRONICS PTE LTD; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

C&W Electronics Pte Ltd in Singapore seeks a Quality Assurance professional to manage ISO 9001 and ISO 13485 audits, lead CAPA activities, and improve processes across departments. You will coordinate with suppliers and production to reduce nonconformities and ensure regulatory compliance.

Role emphasizes calibration oversight, document control, and liaison with external auditors to uphold CW’s global standards.

Qualifications

• Proven audit experience with ISO 9001 and ISO 13485.
• Strong root cause analysis skills (8D, Six Sigma).
• Excellent communication with auditors and cross-functional teams.
• Familiarity with regulatory reporting (RoHS, REACH, Conflict Minerals).
• IPC/WHMA-A-620 knowledge is a plus.
• Sheet metal fabrication/processes experience is a plus.

Responsibilities

• Lead internal and external quality audits and manage findings.
• Prepare audit documents and liaise with CW, customers and auditors.
• Develop QA control and inspection procedures for incoming and finished goods.
• Coordinate with suppliers and production to address nonconformities.
• Maintain calibration program and instrument maintenance schedules.
• Generate 8D/6 Sigma reports and root cause analysis.
• Support management reviews and quarterly audit cycles.

Skills

Audit experience

Root cause analysis

Regulatory compliance

Communication with auditors

Six Sigma

RoHS/REACH knowledge

IPC/WHMA-A-620

Job description

C&W Electronics Pte Ltd in Singapore seeks a Quality Assurance professional to manage ISO 9001 and ISO 13485 audits, lead CAPA activities, and improve processes across departments. You will coordinate with suppliers and production to reduce nonconformities and ensure regulatory compliance.

Role emphasizes calibration oversight, document control, and liaison with external auditors to uphold CW’s global standards.