Customer Quality Assurance Engineer (PCB)
Great opportunity in stable company.
Exposure to cutting-edge technologies.
About Our Client
A leading global technological manufacturer with a large R&D team, my client offers Electronics Manufacturing Services (EMS) focused on delivering world-class design, engineering and manufacturing services for medical devices, networking and communications, 3D printing and imaging, printed circuit board, computer data storage and industrial products.
Responsible for ensuring all product, process and system quality conform to customers' specifications and internal quality system requirements, my client is recruiting a Customer Quality Engineer to ensure product quality is in place and customer satisfactory.
The Successful Applicant
- Key account to manage several life science and other PCB product line.
- Perform root causes analysis and reject investigation for product fallout.
- Perform reliability test rejects to improve field return rate for continual improvement.
- Perform first level analysis on material related issues, familiar with process mapping and RCFA using Fish-bone diagram and 5 Whys methodologies.
- Review and ensure First Article inspection report is acceptable with first submission, submitted on time, and supported with all required documentation.
- Perform internal and external corrective actions and RMA issues (CAR, audits).
- Perform manufacturing process evaluation complying with ISO requirements.
- Perform IQ, OQ, PQ validation and risk management (ISO 14971).
- Ensure compliance to audit findings in timely manner.
- Devise quality procedure, work instruction and quality plan for overall quality control in accordance to NPI procedure.
- Engage customer quality counterparts and resolve daily quality issues while providing timely analysis report to customer on S-CAPA.
What's on Offer
- Diploma/ Bachelor Degree in Engineering with 2 years working experience.
- Experience in Life Science/ Medical Device manufacturing processes and familiar with PCB/ PCBA manufacturing/box build assembly.
- Experience in using quality tools and design analysis tools such as PPAP, FMEA, Control Plan, Quality Plan, QC Seven Tools, CAPA Methodology (ie. using 8D, 5-whys, Cause & Effect Diagram, etc.), GR&R and SPC.
- Familiarity in ISO 9001, ISO 13485, and FDA 21 CFR Part 820.
- Strong communication and presentation skill as this role is client-facing.