Quality Engineer

C & W ELECTRONICS PTE LTD
  • Job category
    Engineering
  • Job level
    Professional
  • Contract type
    Permanent, Full Time
  • Location
    East
  • Salary
    S$2500 - S$4000

Job Description

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): 1.1 Liaise with auditor; 1.2 Prepare auditing documents needed; 1.3 Review and make changes as per required by auditor.

Customer Audit: 2.1 Liaise with auditor; 2.2 Prepare auditing document needed; 2.3 Review and make changes as per required by auditor.

Supplier's Audit: 3.1 Conduct qualification audit as per CW's requirement; 3.2 Conduct surveillance audit as per CW's requirement.

Report

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.

Requirements

ISO 9001, ISO 13485 Audit experience;

Experience in Quality and Electrical Engineering.


Closing on 23 Apr 2021

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