Senior Quality Engineer – Medical Devices (ISO 13485)

RECRUITPEDIA PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

RECRUITPEDIA PTE. LTD. is seeking Senior/Quality Engineer for a leading medical devices manufacturer in Singapore's East region. The role emphasizes QMS support, quality activities across manufacturing, and resolving issues to improve product reliability.

You will collaborate with Engineering, Manufacturing, and Operations, perform inspections, analyze data, assess risks, and participate in audits and CAPA processes. 3–5 years in quality engineering preferred.

Qualifications

• Min 3–5 years in Quality Engineering/QMS.
• ISO 13485 exposure advantageous.
• Familiar with 8D, 5-Why problem solving.

Responsibilities

• Support quality activities across manufacturing processes, products, and daily operations.
• Perform or support product inspection, testing, verification, and process evaluation.
• Gather and analyse quality data to identify trends, support investigations, and improve process performance.
• Investigate quality concerns raised by customers, production teams, and internal stakeholders, and assist in identifying root causes.
• Coordinate follow-up actions for customer complaints, non-conformities, and process-related issues.
• Assist in implementing corrective and preventive actions to address recurring quality issues.
• Participate in risk assessment, failure analysis, PFMEA, and other quality improvement activities.
• Work closely with Engineering, Manufacturing, Operations, and other teams to resolve quality issues and improve processes.
• Support Quality Management System requirements and participate in internal, customer, supplier, and external audits.
• Maintain quality records, procedures, work instructions, reports, and other controlled documentation.
• Participate in continuous improvement projects to enhance product quality, process efficiency, and reliability.
• Perform any ad-hoc duties as assigned.

Skills

Quality Engineering

QMS

Root Cause Analysis

8D

5-Why

Regulated Environments

Data Analysis

Education

Engineering/Science Degree

Tools

N/A

Job description

RECRUITPEDIA PTE. LTD. is seeking Senior/Quality Engineer for a leading medical devices manufacturer in Singapore's East region. The role emphasizes QMS support, quality activities across manufacturing, and resolving issues to improve product reliability.

You will collaborate with Engineering, Manufacturing, and Operations, perform inspections, analyze data, assess risks, and participate in audits and CAPA processes. 3–5 years in quality engineering preferred.