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
Pay: $3,000.00 - $3,600.00 per month
Work Location: In person