Quality Engineer (ISO 13485 | Medical Devices) - #1099352

• Well Established Medical Device Manufacturing Company

• Basic $4500 - $5500 + Allowance +  AWS + Variable Bonus

• Excellent Welfare and Benefits + Career progression

• Working location: Boon Lay

• Working day: Monday to Friday

• Working hours: 8.30am to 5.30pm

• QMS | ISO-13485 | Product Quality Control

Job Responsibilities:

• Conduct assessment and review on supplier qualification, performance and process capability

• Ensure supplier quality issues are deal with, analysed, improved and follow through     

• Collect, handle and follow-up on customer feedback/complaints

• Support internal, external and customer audits

• Evaluation, verification and validation of new parts/samples     

• Establish and maintain inspection criteria for incoming, in-process and final products

• Identify quality issues, NCR, CAPA handling and drive continuous improvement    

• Authorize the release (COC) of products, COA review & approval    

• Monthly data analysis on product quality and quality objective  

• Review and approval on DHR    

• Participate in new projects, commercial product quality management and control    

• Drive change management and control    

• Other ad hoc duties as assigned

Job Requirements:

• Possess minimum Diploma/Degree in relevant subject area with minimum 3 years’ experience in medical device QA and/or RA

• ISO 13485:2016 certified internal auditor will be advantageous

• Familiar with quality control tools

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities

• Current and Expected salary

• Reason for leaving

• Date of availability

• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492