QA Engineer/Medical Devices (ISO 13485/$4500)

Location – Tuas

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

Interested applicants, kindly furnish us with your full and detailed resume in MS Words format and click "Apply Now" button.

EA License No: 10C3364

EA Personnel: (Linda) Lau Ng Eng

EA Personnel Reg No: R1111325