Medical Device Production Quality Engineer - Singapore

DART SOLUTIONS PTE. LTD.; Singapore; Vor Ort; SGD 33.000 - 56.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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

Kenntnisse

Analytical thinking

Problem solving

Cross-functional collaboration

Documentation

Communication

Ausbildung

Mechanical/ Biomedical/ Manufacturing Eng

Tools

CAPA

FMEA

SPC

MSA

Jobbeschreibung

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.