Project Engineer (CM) - ISO13485(Medical Devices)

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:

. Degree or Diploma in mechanical engineering, Electrical Electronic & Engineering or a related field.

. Minimum of 12 years of working experience in project coordinator/management or in related field.

. Strong understanding of Medical device regulations and standards

. Good in written and verbal communication skills

Send your resume to [Confidential Information]

EA License No: 10C3364

EA Personnel: (Linda) Lau Ng Eng

EA Personnel Reg No: R1111325