Quality Engineer: ISO 13485/9001 Compliance

C & W Electronics Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

C&W Electronics Pte Ltd is seeking a Quality Auditor/QA Engineer to uphold ISO 9001 and ISO 13485 compliance across the organization. You will develop, implement, and maintain quality systems and controls, and conduct internal and external audits.

You will coordinate with production, procurement, and suppliers to address nonconformities, drive 8D/Six Sigma reports, and ensure regulatory reporting for RoHS, REACH, and related standards.

Qualifications

• Proven audit experience with ISO 9001 and ISO 13485
• Able to communicate effectively in both English and Mandarin to liaise with Chinese-speaking internal and external stakeholders.
• Experience in Quality Engineering, with exposure to electrical/electronic manufacturing processes
• Strong root cause analysis skills (e.g., 8D, Six Sigma methodologies)
• Familiarity with regulatory/compliance reporting (RoHS, REACH, Conflict Minerals)
• Excellent communication skills for liaising with auditors, suppliers, and cross-functional teams
• Experience with IPC/WHMA-A-620 standard is a plus
• Experience in sheet metal fabrication/processes is a plus

Responsibilities

• Understand CW ISO 13485 quality system and be responsible for developing and implementing quality system and control for ISO 13485 and ISO 9001
• Ensure organizational activities comply with established quality policy, procedures, and applicable international/national medical device regulations and standards
• Plan and conduct management reviews and document findings
• Test instrument calibration; arrange yearly calibration and maintenance schedules
• Develop and implement quality control and inspection procedures for receipt and control of incoming materials, in-process materials and final product acceptance
• Liaise with procurement and supplier for nonconforming materials and Finished Goods; issue RMA numbers
• Identify root causes of rejects and issue 8D/Six Sigma reports; implement corrective actions to prevent recurrence
• Conduct internal audits and prepare audit reports; discuss findings with management
• Coordinate external audits (TUV, CSA, UL) and customer/supplier audits; review documentation as required
• Generate required compliance reports (ROHs, REACH, Conflict Minerals) and support appropriate documentation

Skills

Audit experience

Quality engineering

Bilingual English/Mandarin

Job description

C&W Electronics Pte Ltd is seeking a Quality Auditor/QA Engineer to uphold ISO 9001 and ISO 13485 compliance across the organization. You will develop, implement, and maintain quality systems and controls, and conduct internal and external audits.

You will coordinate with production, procurement, and suppliers to address nonconformities, drive 8D/Six Sigma reports, and ensure regulatory reporting for RoHS, REACH, and related standards.