Duties & Responsibilities:

·         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

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

·         · 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

Preferred Qualifications:

·         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 advantages.

·         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

Education:

·         Diploma and B.S. in Mechanical Engineering, Electrical Engineering, Manufacturing, Mechatronics or Industrial Engineering.