C & W ELECTRONICS PTE LTD
Permanent, Full Time
S$2500 - S$4000
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;
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.
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.
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.
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.
ISO 9001, ISO 13485 Audit experience;
Experience in Quality and Electrical Engineering.
Closing on 23 Apr 2021orview more job listings from this company