QA 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:
- ROHs 1 compliance Declaration Report
- ROHs 2 compliance Declaration Report
- REACH compliance Declaration Report
- 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 Duration of Contract: 12 Months