SENIOR QUALITY ENGINEER [ SENAI / PCBA & ISO 13485 ]
Specialisation: Manufacturing/Production Operations
Education Qualification: Bachelor Degree
Post Graduate Diploma
Post Graduate Diploma
Work Location : Senai, Johor
Salary Range : RM 5,000.00 – 7,000.00
Posted Date : October 25, 2019
SENIOR QUALITY ENGINEER
- Job Responsibility
- Lead on engineering for Cardiac Science Medical (AED) & Hitachi Healthcare (Ultrasound) projects
- Utilize customer package and create the process flow, documented in (Work Instruction) and apply the process to production manufacturing.
- Lead to perform NPI and FA Report for new models or products.
- Design/ improve stencil and wave pallet for production.
- Design/ improve jigs and fixtures for production.
- Cycle time & line balancing study to improve production output & productivity.
- Control and maintain BOM, ECO, AVL and MPN in system (ODC, Citrix, Matrix & ETQ).
- Process control for SMT PCBA assembly for medical equipment/ product.
- Provide DFM (Design for Manufacturability) inputs to Design Team during NPIs. Continuous communication with customer to get better understanding on their requirements.
- Transfer necessary Product Knowledge from customer to internal parties i.e. Trainers, Process Engineers, etc.
- Lead in equipment validation protocol & reports (IQ, OQ and PQ) for new line setup & new product validation.
- Involvement in kaizen & lean six sigma activities to re-layout box build line by separating sub assy line from main assy process.
- Using the same operator for both sub & main assy line. Re-train the operators & reduce headcount.
- Lead engineering activities to establish containment action and root-cause in the event of Product Quality Issues, Low Yields, Quality Reject, Product failures, etc.
- Trouble-shoot, analyze and resolve Process & Product related failures
- Candidate must possess at least a Professional Certificate, Diploma, Advanced/Higher/Graduate Diploma, Bachelor's Degree, Post Graduate Diploma, Professional Degree, Engineering (Electrical/Electronic), Engineering (Industrial), Engineering (Mechanical), Engineering (Others), Engineering (Mechatronic/Electromechanical) or equivalent.
- At least 5 year(s) of working experience in the related field is required for this position. Preferably Senior Executives specializing in Engineering – Industrial or equivalent.
- PCBA experience and ISO 13485 knowledge preferable
- Excellent Verbal and written communication skills.
- Able to work independently.
- Required : Experience in Box Build and Medical Class III (OQ, PQ validation)
Kindly contact the following consultant at 07-2305453 for further details or send your resume to Mr Nicholas [ email@example.com ]