Senior QA Engineer / Quality Engineer – Medical Devices (ISO 13485 / Supplier & Product Quality)

EA RECRUITMENT PTE. LTD.; Singapore; On-site; SGD 100,000 - 125,000; Full time

Job summary

A leading company in the medical device sector seeks a Quality Assurance Engineer to evaluate suppliers and manage quality initiatives. The successful candidate will have a strong grasp of ISO 13485 and relevant experience in quality assurance within a manufacturing setting. This role offers competitive compensation and opportunities for career advancement.

Benefits

Excellent Welfare and Benefits

Career Progression Opportunities

Qualifications

• Minimum 3 years in medical device QA/RA, especially in manufacturing.
• Strong understanding of ISO 13485:2016; internal auditor certification is a plus.
• Experience with supplier quality management and quality tools.

Responsibilities

• Evaluate and qualify new suppliers and monitor ongoing supplier performance.
• Conduct evaluation, verification, and validation of new components.
• Analyze quality data and prepare monthly reports on product performance.

Skills

Supplier Quality Management

CAPA

Root Cause Analysis

FMEA

ISO 13485:2016

Education

Diploma or Degree in Engineering, Quality, or related field

Tools

Quality Tools

Job description

• Well Established Company
• Basic $4500 - $6000 + 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
  

Job Responsibilities:

• Evaluate and qualify new suppliers, and monitor ongoing supplier performance and process capability.
• Investigate and resolve supplier quality issues with effective root cause analysis and corrective actions.
• Manage customer complaints and feedback by coordinating cross-functional responses and implementing improvements.
• Support internal and external audits (ISO 13485, customer audits).
• Conduct evaluation, verification, and validation of new components and parts.
• Define and maintain inspection criteria for incoming materials, in-process checks, and final product release.
• Handle non-conformance reports (NCRs), lead CAPA processes, and drive continuous improvement initiatives.
• Review Certificates of Conformance (COC) and Certificates of Analysis (COA); authorize product release.
• Analyze quality data and prepare monthly reports on product performance and quality KPIs.
• Review Device History Records (DHR) and ensure compliance.
• Participate in new product development and ensure quality standards are integrated throughout the lifecycle.
• Manage engineering changes and document control related to quality systems.
  

Job Requirements:

• Diploma or Degree in Engineering, Quality, or related field.
• Minimum 3 years of working experience in medical device QA/RA, especially in a manufacturing environment.
• Strong understanding of ISO 13485:2016 – internal auditor certification is a plus.
• Experience with supplier quality management, CAPA, and quality tools (e.g. FMEA, 8D, RCA).
  

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.

NG DIAUM YEE (R2198031)

EA Recruitment Pte Ltd

EA License No: 21C0492