Quality Engineer (ISO 13485 | Medical Devices)

EA RECRUITMENT PTE LTD; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A well-established medical device manufacturing company in Boon Lay is seeking a Quality Assurance professional. This role involves supplier qualification assessments, quality issue management, and participation in audits. The ideal candidate will possess a relevant diploma or degree and a minimum of 3 years’ experience in the medical device sector with advantageous ISO 13485 certification.

Benefits

Excellent Welfare and Benefits

Career progression opportunities

Qualifications

• Minimum 3 years’ experience in medical device QA and/or RA.
• ISO 13485:2016 certified internal auditor advantageous.
• Familiar with quality control tools.

Responsibilities

• Conduct assessments and reviews on supplier qualifications and processes.
• Support internal, external, and customer audits.
• Identify quality issues and drive continuous improvement.

Skills

Quality Control

Auditing

Process Improvement

Education

Diploma/Degree in relevant subject area

Job description

• Well Established Medical Device Manufacturing Company

• Basic $5000 - $6000 + 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