Senior/Quality Engineer (Medical Device Manufacturing) / East

RecruitPedia Pte Ltd; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

RecruitPedia Pte Ltd's client, a leading medical devices manufacturer in Singapore's East, is seeking Senior/Quality Engineer to strengthen the quality team and drive compliance.

You will support quality activities across manufacturing, perform inspections, analyze data, investigate customer complaints, and participate in audits and continuous improvement projects; strong teamwork required.

Qualifications

• Diploma or degree in Engineering, Science or a related technical field.
• 3–5 years of experience in Quality Engineering / QMS.
• Exposure to regulated environments or ISO 13485 is a plus.
• Familiar with 8D and 5-Why problem-solving approaches.

Responsibilities

• Support quality activities across manufacturing processes, products, and daily operations.
• Perform or support product inspection, testing, verification, and process evaluation activities.
• 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 data analysis

8D problem solving

5-Why analysis

PFMEA

Internal audits

Education

Diploma or Degree in Engineering/Science

Job description

Our client is one of the leading players in the medical devices manufacturing sector. Due to their current expansion plan, they are looking for a multiple headcounts of Senior/Quality Engineer to join their team, in hopes of developing the current high performing team. They are located in the East area.

Job Responsibilities:

• Support quality activities across manufacturing processes, products, and daily operations.
• Perform or support product inspection, testing, verification, and process evaluation activities.
• 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.

Requirements:

• Min Diploma or Degree in Engineering, Science, or a related technical field.
• Min 3-5 years of relevant experience in Quality Engineering/QMS.
• Exposure to regulated environments or ISO 13485 will be an advantage.
• Familiar with quality and problem-solving tools such as 8D, 5-Why, etc. will be advantageous.

We regret that only shortlisted candidate will be notified.