Senior / QA 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 well-established company in Singapore is seeking a Quality Assurance Specialist to handle supplier management, resolve quality issues, and ensure compliance with ISO standards. The ideal candidate should have a relevant diploma/degree and 3 years of experience in QA within the medical device sector. This role offers a competitive salary and excellent benefits, with opportunities for career progression.

Benefits

Excellent welfare and benefits

Career progression

Qualifications

• Minimum 3 years experience in medical device QA/RA.
• Strong understanding of ISO 13485:2016; internal auditor certification is a plus.

Responsibilities

• Evaluate and qualify new suppliers and monitor ongoing performance.
• Investigate and resolve supplier quality issues.
• Manage customer complaints and feedback.

Skills

Supplier Quality Management

CAPA

FMEA

Root Cause Analysis (RCA)

Education

Diploma or Degree in Engineering, Quality, or related field

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 viaApply Nowbutton 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