Senior / Quality Engineer X 2 ( ISO 13485 / Medical Devices / Quality Assurance / Quality Control)

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

Job summary

A leading company in the medical devices sector is seeking a QA professional for supplier qualification and quality management. The role involves ensuring adherence to ISO standards, analyzing supplier performance, and driving quality improvements. This full-time position offers competitive salary and excellent benefits with career progression opportunities.

Benefits

Excellent Welfare and Benefits

Career progression

Qualifications

• Minimum 2 years’ experience in medical device QA and/or RA.
• ISO 13485:2016 certified internal auditor will be advantageous.

Responsibilities

• Conduct assessment and review on supplier qualification, performance and process capability.
• Ensure supplier quality issues are dealt with and drive continuous improvement.
• Support audits and evaluate new parts/samples.

Skills

Quality control tools

Education

Diploma/Degree in relevant subject area

Job description

• Well Established Company
• Basic $5000 - $6500 + 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 | Medical Devices
  

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 2 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