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Mô tả công việc
· The following processes are key to IPQC performance within Nextern and between Nextern and our key customer collaborators. This role must be proficient at achieving outcomes on-time, with high quality documentation content, and cross-functional team awareness/support (internal & external).
o CAPA & SCAR Processes
o Process Qualification & Validation
o Equipment (Functional Test, Assembly Fixtures, Manufacturing Aids, etc...) Selection & Qualification
o Process Control & Yield/Trend Monitoring
o Return Material Authorization (Customers to Nextern)
o Return Material Authorization (Intra Nextern)
o Failure Analysis of Returned Products (Out of Box & Fielded)
o Servicing & Refurbishment of Fielded Products
o Non-Conforming Material Processing (Manufacturing, Supplier, & Engineering Change Causes)
o Create required documentation that relevant to product specifications and requirements (Process flow, control plan, inspection criteria...)
o Manage inspection report follow AQL for each shipment.
· The following processes are key to IQC performance
o Prepare Incoming Inspection Criteria. Ensure that all related inspection and testing activities with regards to the established standards.
o Control inspection materials in both ERP system and physical.
o Maintain record of inspection, testing, equipment calibration, maintenance, etc. per procedures. Scan & archive records in the control system.
o Initiate timely CAPA, SCAR, Non-Conforming Material Processing and follow up
o Perform the Equip/Process Qualifications. Control of Equipment Calibration & Preventive Maintenance.
o Material Issue Investigation Lead, Scrap/NCM Lead, Traceability Lead
o Initialize PPAP (Production Part Approval Process) to supplier, gather and maintain all required documentation.
o Maintains PPAP master samples
o Travel to supplier locations to conduct audits and inspections
o Build excellent quality reports.
Yêu cầu
Qualification and Skill
o Bachelor degree or higher (Prefer candidate have experience in medical device)
o Minimum 4 years' experience in process quality management.
o Have experience on manage people and training at least 2 years.
o ISO9001:2015 certification is mandatory (ISO13485 certification is preferred)
o Experience in Solving problem (follow 8D).
o Experience in FMEA as a leader.
o Experience in process qualification.
o Expert in process capability and control, Minitab.
o Excellent in excel (especially VBA), word, excel and PowerPoint.
o Language: must be highly fluent in English (written & verbal).
o Very good in presentation and communication, especially in English.
o Leadership behavior is preferred.
o Knowledge about improving concept (Kaizen, 6 sigma, lean manufacturing...).
Physical Demands and Work Environment:
Able to work overtime and accept meeting at night several times weekly.
Able to work under high pressure.
Able to work in clean room.
· Technical Expertise: The following product types will require technical leadership and expertise to contain issues, determine root cause of issues, drive corrective actions internal to Nextern and collaboratively with customer collaborators, and collaborate with the supplier management organization on effective corrective/preventive actions to be implemented by the supplier, as needed.
o Printed Circuit Board Assemblies
o Pneumatic Pumps & Valves
o Cables & wired interconnect assemblies
o Molded Plastic Parts (including pad/laser print suppliers)
o Gluing, Mating, and Fastening Processes for Enclosures
o Displays
o Power Supplies
o Mechanical fastener & chassis components
o Electromechanical connectors & fasteners
Strong of reading and understanding technical drawing.
Quyền lợi
LÀM VIỆC TẠI KCN MỸ PHƯỚC 3 - BẾN CÁT - BÌNH DƯƠNG
Thời gian làm việc: thứ 2 - thứ 6
Thông tin khác
- Chức vụ: Trưởng nhóm
- Kinh nghiệm: Hơn 5 năm kinh nghiệm
- Hình thức làm việc: Toàn thời gian cố định
- Yêu cầu bằng cấp: Đại học trở lên
- Yêu cầu giới tính: Nam
- Số lượng cần tuyển: 1 ứng viên
- Thời gian thử việc: 1 tháng
- Ngành nghề:
Thẩm định - Giám thẩm định - Quản lý chất lượng
- Lĩnh vực:
kỹ sư qa qc
Hồ sơ bao gồm
- Đơn xin việc.
- Sơ yếu lý lịch.
- Hộ khẩu, chứng minh nhân dân và giấy khám sức khoẻ.
- Các bằng cấp có liên quan.
Thông tin chung
- Ngày hết hạn: 30/08/2022
- Thu nhập: Đến 27.000.000 VNĐ