Quality Engineer/Medical Devices (ISO 13485/$4600)

Forte Employment Services Pte Ltd; Singapore; Presencial; SGD 30 000 - 50 000; Tempo integral

Resumo da oferta

Forte Employment Services Pte Ltd is seeking a Quality Inspection professional to oversee assembly processes for medical devices at our Tuas/Woodlands site. You will coordinate IQ/OQ/PQ activities and ensure products meet ISO 13485 and FDA 21 CFR Part 820 standards.

The role requires a Diploma or Bachelor’s in Engineering and 3–5 years in quality inspection within precision manufacturing, with strong CMM and GD&T skills, and experience in FMEA, 8D, RCA, and SPC. Singaporean candidates preferred.

Qualificações

• Diploma or Bachelor Degree in Engineering or related field.
• Minimum 3–5 years of experience in a quality inspection role within precision machining or high-tolerance manufacturing.
• Proficient in using precision measuring instruments and advanced inspection tools (CMM, vision systems).
• Strong understanding of GD&T and ability to read complex engineering drawings.
• Experience with quality tools and methodologies such as FMEA, 8D, Root Cause Analysis, and SPC.

Responsabilidades

• Manage project schedule: plan, coordinate, and oversee assembly processes of medical devices or equipment.
• Lead or support IQ/OQ/PQ activities.
• Develop and maintain engineering documentation, including procedures, processes and quality plans, drawings, and specifications.
• Ensure work quality and schedule adherence.
• Interpret and execute customer specifications to provide suitable engineering solutions.
• Communicate with customers to understand their needs and requirements.

Conhecimentos

Reading eng. drawings

FMEA

8D

SPC

Communication with customers

Formação académica

Diploma or Bachelor Degree in Engineering

Ferramentas

CMM

Vision systems

Descrição da oferta de emprego

Location – Tuas, Woodlands

Working Hours – 8.30am to 6pm/5days

Salary - MAX 4500

MUST experience in CMM

Key Responsibilities:

Manage project schedule: To plan, coordinate, and oversee the assembly processes of medical devices or equipment, ensuring that production meets design specifications, regulatory standards ISO 13485(Medical Devices QMS) and FDA 21 CFR Part 820(QSR) and project deadlines.

• Lead or support IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) activities.
• Develop and maintain engineering documentation, including procedures, processes and quality plan, drawings, and specifications.
• Ensure work performed within desired quality and stipulated schedule.
• Ensure customer’s specification and requirements understood and executed as to provide good engineering solutions.
• Communicating with customers, interpreting their needs and requirements.

Requirements

• Diploma or Bachelor Degree in Engineering or related field.
• Minimum 3- 5 years of experience in a quality inspection role within precision machining or a high-tolerance manufacturing environment.
• Proficient in using precision measuring instruments and advanced inspection tools (CMM, vision systems).
• Strong understanding of GD&T and ability to read complex engineering drawings.
• Experience with quality tools and methodologies such as FMEA, 8D, Root Cause Analysis, and Statistical Process Control (SPC).
• SINGAPOREAN

EA License No: 10C3364

EA Personnel: (Linda) Lau Ng Eng

EA Personnel Reg No: R1111325