Quality System Assistant

Job Description (Draft)

Position : Quality System Assistant

Organization

• Function: Quality
• Country:  China
• Location: Suzhou
• Direct Report: QS Engineer / Quality Manager

Purpose

The Quality System Assistant plays a key role in the quality management system, primarily responsible for assisting in the implementation, maintenance, and improvement of the quality system. This ensures that the company's products and services meet the established quality standards and regulatory requirements, thereby enhancing customer satisfaction and strengthening the company's competitiveness in the market.

• As the assist supporting QS Engineer work;
• As the DCC of NSZ plant, responsible for company document control work;
• As the statistical officer responsible for NSZ plant all functions KPI data collection and customer specific report preparation.

Areas of responsibility

• Quality Auditing and Assessment: Assist in conducting internal and external quality audits, covering inspections of production processes, document records, equipment facilities, etc., to ensure that all operations comply with the provisions of the quality management system. Participate in the quality assessment and audit of suppliers to ensure that raw materials and components meet quality standards.
• Document Management and Maintenance: Be responsible for organizing, archiving, and updating documents related to the quality management system, such as Standard Operating Procedures (SOPs), quality manuals, record forms, etc., to ensure the accuracy and traceability of documents. Manage the storage of quality documents to ensure their security and confidentiality.
• Data Collection and Analysis: Collect and organize data related to quality, such as quality inspection results, customer complaints, nonconforming product records, etc., and conduct data analysis to provide a basis for quality improvement. Assist in generating quality reports to report on the quality status and the implementation effects of improvement measures to management and relevant departments.
• Quality Training and Communication: Assist in organizing and conducting quality training activities to convey the requirements and standards of the quality management system to employees, enhancing their quality awareness and operational skills. Maintain good communication with various departments to promptly resolve quality-related issues and conflicts.
• Project Support and Coordination: Assist the Quality Manager or Supervisor in carrying out quality improvement projects, such as Six Sigma projects, lean production projects, etc., to promote the continuous improvement of the quality management system. Coordinate cross-departmental quality projects to ensure their smooth progress.
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Position sizing

• Quality KPIs data collection and analysis;
• QMS audit handling
• DCC in acceptable level

Expected Results

• On site un-DCC document NCs ;
• External QMS audit major findings, Minor findings;
• Customer specific FQC report time-control and NCs;

Required skills and qualifications

• Typically requires a high school diploma or above;
• 5 years work experience, replated is a plus;
• Familiarity with quality management system standards such as ISO 9001, ISO 13485, cGMP, etc.;
• Good document management and document control capabilities;
• Proficient in using office software, such as Microsoft Word, Excel, PowerPoint, etc.
• Good communication skills and team spirit.
• Be meticulous, responsible, and able to pay attention to details.
• Be able to work under pressure and complete tasks on time.
• Have strong learning and adaptability skills, and be able to quickly grasp new knowledge and skills.
• Can read and understand English documents and simplify communication is a plus.