Project Engineer (CM) - ISO13485(Medical Devices)
Summary
Oversee assembly and qualification of medical devices to ISO 13485 and FDA QSR standards, coordinating schedules, documentation, and customer requirements.
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 1~2 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 linda@forteemp.com.sg
EA License No: 10C3364
EA Personnel: (Linda) Lau Ng Eng
EA Personnel Reg No: R1111325