Quality Engineer

Job Description:

• Understand CW ISO 13485 quality system, be responsible in developing and implementing quality system and control for ISO 13485 and ISO 9001
• Ensures organizational activities comply with established quality policy, procedures, and applicable international/national medical device regulations and standards
• Management Reviews Meeting
• Conduct management review meeting every 6 months and/or as required
• Discuss findings
• Document management review meeting
• Test instrument calibration
• Send instruments for yearly calibration and/or as required
• Maintain test instrument calibration procedures 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 activities
• Nonconforming incoming materials
• Liaise with procurement and supplier
• Nonconforming Finished Goods
• Issue RMA number
• Find out root cause of rejects and issue 8D / 6 Sigma Report
• Put up quality alert and work with production to ensure that reject does not take place again
• Internal Audit
• Plan and conduct quarterly audit and/or as required
• Document and discuss findings with management
• Work with different departments to improve their system with findings
• External Audits
• Third Party Certification Audit (TUV,CSA & UL): Liaise with auditor; Prepare auditing documents needed; Review and make changes as per required by auditor.
• Customer Audit: Liaise with auditor; Prepare auditing document needed; Review and make changes as per required by auditor.
• Supplier's Audit: Conduct qualification audit as per CW's requirement; Conduct surveillance audit as per CW's requirement.

• Reports:

1. ROHs 1 compliance Declaration Report

2. ROHs 2 compliance Declaration Report

3. REACH compliance Declaration Report

4. CFSI-CMRT: Conflict Mineral Reporting

• Handle Customers' complaints;
• Perform other duties/projects as required or assigned from time to time.

Job Requirements:

• Proven audit experience with ISO 9001 and ISO 13485
• 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