Thông tin công việc
Mô tả
– Develope and initiate standards and methods for inspection, testing and evaluation on sub-system and system integration.
-Able to communication at all levels to enhance efficiency and productivity.
-Actively assure compliance to ISO 9001:2005 and ISO 13485:2016, company policies and regulatory requirements.
-Implement quality planning, control plan, FMEA, inspection methodology.
-Able to manage and drive Material Review Board (MRB) and Returned Material Authorization (RMA).
-Able to lead Root cause analysis and implementation of Corrective Actions & Preventive Actions (CAPA).
-Work with Engineering and ensure Engineering Change Order (ECO) implementation in timely maner.
-Able to lead internal audit and manage tooling calibration program.
-Report any deviations on non-conformance promptly to managers for immediate actions.
-Support Manufacturing Engineers and Program Managers. Complete projects on time as assgined.
Yêu cầu
-Thorough understanding of continuous process improvement tools.
- Knowledge and experience with implementation of ISO 9001 andISO13485 quality systems.
-Must be a team player with ability to promote collaboration, taking ownership and/or facilitating process achievements.
-Demonstrate deep understanding of quality metrics, RMA, MRBand ECO
-Good communication in English- both written and oral.
-Proficient with Microsoft Office (i.e. Word, Excel, Outlook and PowerPoint).
-At least 3 to 5 years in manufacturing or quality engineering fields.
Education:
- Bachelor's degree in Mechanical Engineering or a related discipline, or equivalent qualificatons base on demonstrated experience
- Bằng cấp:
Đại học - Độ tuổi:
30 - 45
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