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