Production Quality Engineer (Medical Device)

DART SOLUTIONS PTE. LTD.; Singapore; On-site; SGD 33,000 - 56,000; Full time

Job summary

DART SOLUTIONS PTE. LTD.

is seeking a Production Quality Engineer to strengthen production quality, drive process improvements, validation, and regulatory compliance in a Singapore-based medical device manufacturing environment. The role focuses on investigating manufacturing issues, implementing corrective actions, and enhancing process capability while ensuring product conformity under regulated conditions.

Qualifications

• Diploma or Degree in Mechanical, Biomedical, Manufacturing Engineering or related discipline.
• Experience in medical device manufacturing or another regulated industry.
• Understanding of ISO 13485, GMP, and FDA QMSR requirements.

Responsibilities

• Lead investigations into product and process non-conformances.
• Conduct root-cause analysis using structured methods (5 Whys, Fishbone, FMEA).
• Drive CAPA and verify effectiveness of corrective actions.
• Support IQ/OQ/PQ validation of equipment, processes, and test methods.
• Work with Production to resolve manufacturing failures and quality issues.
• Monitor process capability, stability, yield, and defect performance.
• Apply quality tools including SPC, MSA, and FMEA.
• Drive Lean / Kaizen and continuous improvement activities.
• Support internal, customer, and regulatory audits.
• Prepare quality metrics, trend analysis, and management reports.
• Support risk management per ISO 14971

Skills

Analytical thinking

Problem solving

Cross-functional collaboration

Documentation

Communication

Education

Mechanical/ Biomedical/ Manufacturing Eng

Tools

CAPA

FMEA

SPC

MSA

Job description

Production Quality Engineer (Medical Device) - Singapore

Singapore | Quality Engineering | Medical Devices | Manufacturing | Production | Quality Assurance| ISO13485 | ISO 14971 | IQ/OQ/PQ | GMP | FDA QMSR

Salary up to SGD 5,000/month

About the Role

A growing medical device manufacturing team in Singapore is looking for a Production Quality Engineer to support production quality, process improvement, validation, and quality management activities.

This is a hands-on role focused on investigating manufacturing issues, driving corrective actions, improving process capability, and maintaining product conformity within a regulated medical device environment. Ideal for someone who enjoys working closely with Production and Engineerin , solving practical manufacturing problems, and driving continuous improvement.

About the Company

The company is a Singapore-based contract manufacturer supporting global medical device OEMs and operates within a regulated manufacturing environment. With ISO 13485:2016 certification and strong manufacturing capabilities, the organization supports customers across production quality, process validation, quality improvement, and medical device manufacturing.

What's in it for you

• Hands-on exposure to medical device manufacturing and production quality
• Work closely with Production, Engineering, and customers
• Exposure to CAPA, validation, risk management, and quality audits
• Develop experience with ISO 13485, GMP, and FDA QMSR requirements
• Gain practical experience in SPC, MSA, FMEA, and root-cause analysis
• Participate in Lean / Kaizen continuous improvement initiatives
• Opportunity to develop a long-term career in medical device quality engineering

What you'll be doing

• Lead investigations into product and process non-conformances
• Conduct root-cause analysis using 5 Whys, Fishbone, and FMEA
• Drive CAPA and verify the effectiveness of corrective actions
• Support IQ/OQ/PQ validation of equipment, processes, and test methods
• Work with Production to resolve manufacturing failures and quality issues
• Monitor process capability, stability, yield, and defect performance
• Apply quality tools including SPC, MSA, and FMEA
• Drive Lean / Kaizen and continuous improvement activities
• Support internal, customer, and regulatory audits
• Prepare quality metrics, trend analysis, and management reports
• Support risk management activities in accordance with ISO 14971

What we're looking for

• Diploma or Degree in Mechanical, Biomedical, Manufacturing Engineering , or related discipline
• Experience in medical device manufacturing or another regulated industry
• Understanding of ISO 13485, GMP, and FDA QMSR requirements
• Experience with process validation and manufacturing quality tools
• Practical knowledge of CAPA, FMEA, SPC, MSA, and root-cause analysis
• Strong analytical and problem-solving skills
• Good communication and cross-functional collaboration skills
• Experience with customer audits, supplier quality, or Lean Six Sigma is an advantage
• Comfortable working closely with Production and Engineering in a fast-paced manufacturing environment
• Able to work independently while collaborating effectively with cross-functional teams