Quality Engineer (Quality Control / ISO 13485 / QMS)

EA RECRUITMENT PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading company in the medical device sector is seeking a Quality Assurance professional to conduct assessments on supplier qualifications and manage product quality control. The ideal candidate will possess a diploma or degree in a relevant field, with at least 3 years of experience in quality assurance within the medical device industry, along with strong analytical skills for continuous improvement efforts.

Benefits

Excellent Welfare and Benefits

Career progression

Qualifications

• Minimum 3 years’ experience in medical device QA and/or RA.
• ISO 13485:2016 certified internal auditor preferred.

Responsibilities

• Conduct assessment and review on supplier qualification and performance.
• Collect, handle, and follow-up on customer feedback/complaints.
• Establish and maintain inspection criteria for products.

Skills

Quality Control Tools

Education

Diploma/Degree in relevant subject area

Job description

• Well Established 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