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Primary Responsibilities / 主要職責 :
The Lead Quality Engineer will demonstrate leadership in communicating business goals, programs, and processes for an area or business segment. In this role, you will utilize your experience or expertise to solve problems, develop and execute objectives for self and others, and have the ability to effect short-term and some long-term business goals.
- Plan, direct, and coordinate all quality assurance functions for assigned product lines
- Direct and coordinate the overall quality specifications and standards for materials, processes, and finished products to meet customer purchase order requirements
- Plan and coordinate the activities of quality staff by managing quality responsibilities as assigned including: Complaint Data, Compliant CA/PA Planning, Execution, and Effectiveness Checks, Complaint file Closure and Trending
- Support regulatory compliance and optimization of quality systems procedures relating to product complaint handling, adverse event reporting and product field actions through development, maintenance and improvement of documented processes
- Develop and implement quality metrics to drive manufacturing improvements and business results
- Plan and supervise studies aimed at improving product quality and reliability
- Contact customers and suppliers when necessary to confer on specific quality issues
- Assist other departments as necessary in formulating new products, establishing standards for these products prior to initial production, or overcoming difficulties in the use of company products
- Ensure a means of collecting and distributing compiled information in order to improve quality
- Responsible for the administration of the quality system, including implementation an maintenance to regulatory requirements and standards such as applicable ISO standards
- Ensure safe practices are used in compliance with all governmental regulations
- Identify, drive, mentor, and implement projects that improve overall production quality.
- Work with Six Sigma Quality team to drive process changes
- Conduct training to quality processes as needed
- Responsible for the Quality of all in-house manufactured products
- Drive Lean effort within manufacturing focusing on Quality
- Ensure team comply with company policy and process including but not limit in compliance, quality, production. EHS, HR