Quality Engineer

1 day ago


Pasir Ris, Singapore C&W ELECTRONICS PTE LTD Full time

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**
- ISO 9001, ISO 13485 Audit experience
- Experience in Quality and Electrical Engineering

**Job Types**: Full-time, Permanent

**Salary**: $2,500.00 - $2,800.00 per month

**Benefits**:

- Health insurance
- Professional development

Schedule:

- Monday to Friday

Supplemental pay types:

- Performance bonus

Work Location: In person


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