
Assistant Engineer, Process
- Pasir Gudang, Johor
- Tetap
- Sepenuh masa
- Understand the process requirement of all process and equipment in the production area.
- Responsible to maintains process work instructions associated with all manufacturing processes such as manufacturing assembly and in-process acceptance procedures.
- Collaborating with Engineers in developing and implement Visual Aids and Physical Samples on critical steps of the process to indicate proper acceptance criteria.
- Take charge to trains manufacturing staff to released work instructions.
- Managed to execute Process Validation Protocols or/and Transference Plans and help Engineers to generates test reports.
- Maintains and help Engineers to improve process risk assessments, pFMEA
- Able to take lead and supports investigation, disposition, and corrective action of non-conforming materials
- Responsible in identifying areas for improvement, maintaining high levels of manufacturing and product quality
- Maintaining and sustain the statistical process controls (SPC) for manufacturing operations
- Responsible for ensuring cost reduction/process improvement programs
- Experience with optical / electro-mechanical assembly and testing
- Experience in modern manufacturing principles and techniques
- Working knowledge of statistical techniques (e.g., DOE, FMEA, SPC)
- Experience in process automation, verification and validation
- Excellent communication skills and technical writing abilities
- Excellent conceptual, analytical, and problem-solving abilities
- Excellent computer skills - CAD software, word processing, and spreadsheets
- Ability to be work effectively in cross-functional teams
- Technical experience working in high-volume manufacturing environment.
- Experience in application of statistical process controls in a manufacturing environment
- Experience in manual, semi-automated and automation processes, verification and validation
- Hands-on skills with electro-mechanical troubleshooting and diagnostics
- Excellent technical writing abilities
- Good conceptual, analytical, and problem-solving abilities.
- Good computer skills - CAD, word processing, and spreadsheets.
- Ability to be part of a team and adept in building and leading teams.
- Knowledge and experience in FDA QSR requirements and preferably ISO-13485 requirements is an advantage.
- Experience with planning and executing process validations and managing process risk assessment \
- Knowledge on developing and executing saving projects thought lean manufacturing techniques.
- Good English communication skills, both verbal and written, and the ability to effectively interface with Research and Development, Quality Assurance, and other functional groups in the organization