QA Engineer

LUMINA ADVISORY & GLOBAL SEARCH PTE. LTD.; Singapore; Vor Ort; SGD 55.000 - 90.000; Vollzeit

Zusammenfassung

LUMINA ADVISORY & GLOBAL SEARCH PTE. LTD. seeks a meticulous Quality Engineer to support the Quality Department in medical device quality programs, managing customer feedback, and driving improvements across inspection processes and quality procedures.

This role is suitable for candidates with 2–5 years of QA experience in the medical device sector, or fresh graduates with a strong quality mindset. Knowledge of ISO 13485 and quality tools will help you excel in this position.

Qualifikationen

• Diploma or Degree in Chemical Engineering, Materials Science, Manufacturing Engineering, or related field.
• 2–5 years QA experience in medical devices; fresh graduates welcomed.
• Strong analytical, problem-solving, and attention to detail.
• Familiarity with ISO 13485 and quality control tools.
• Proficiency with MS Office.

Aufgaben

• Manage customer feedback, complaints and quality issues, ensuring timely investigation, root cause analysis, corrective action and closure.
• Establish, maintain and improve inspection criteria, specifications and quality standards for incoming materials, in-process production and finished products.
• Identify, document and manage non-conformances, including root cause analysis and CAPAs.
• Review inspection results, approve COCs and COAs, and authorize product release per requirements.
• Review and approve DHR to ensure completeness and compliance.
• Develop, implement and maintain quality procedures, work instructions, inspection methods and QC measures.
• Support internal, external and customer audits, including documentation and follow-up actions.
• Analyze product quality data and performance against objectives to identify trends and improvement opportunities.

Kenntnisse

Analytical thinking

Problem solving

Attention to detail

Proactivity

Ausbildung

Diploma in Chemical Engineering

Degree in Chemical Engineering

Materials Science

Manufacturing Engineering

Tools

Microsoft Office

Quality control tools

Jobbeschreibung

Our client is seeking a meticulous and proactive Quality Engineer to join their Quality Department. You will support product quality and compliance with medical device quality standards, manage customer feedback, and drive improvements across inspection processes and quality procedures.

This opportunity is suitable for candidates with relevant quality assurance experience, as well as fresh graduates keen to build a career in medical device quality engineering.

Key Responsibilities

• Manage customer feedback, complaints and quality issues, ensuring timely investigation, root cause analysis, corrective action and closure.
• Establish, maintain and improve inspection criteria, specifications and quality standards for incoming materials, in-process production and finished products.
• Identify, document and manage non-conformances, including conducting root cause analysis and implementing corrective and preventive actions.
• Review inspection results, approve Certificates of Conformance (COC) and Certificates of Analysis (COA), and authorise product release in accordance with established requirements.
• Review and approve Device History Records (DHR) to ensure completeness and compliance with applicable requirements.
• Develop, implement and maintain quality procedures, work instructions, inspection methods and quality control measures.
• Support internal, external and customer audits, including relevant documentation and follow-up actions.
• Analyse product quality data and performance against quality objectives to identify trends and opportunities for continuous improvement.

Requirements

• Diploma or Degree in Chemical Engineering, Materials Science, Manufacturing Engineering, Science, Engineering or a related discipline.
• Preferably 2-5 years of experience in quality assurance within the medical device industry. Fresh graduates are also welcome to apply.
• Strong analytical, problem-solving and critical-thinking skills, with attention to detail and a proactive approach.
• Proficiency in Microsoft Office applications and familiarity with quality control tools.
• Knowledge of ISO 13485 and/or ISO 9001 requirements.
• ISO 13485:2016 internal auditor certification would be an advantage.