Quality Engineering Manager

Location: Kunshan

Job Requirements and Qualifications:

85 Bachelor's degree in Electrical Engineering, Electronics Engineering, Industrial Engineering, Quality Engineering, or a related technical field.

85 Minimum of 5 years of progressive experience in quality management within medical electronics or medical device manufacturing environment.

85 Proven experience in developing, implementing, and maintaining quality management systems

85 Experience in handling customer quality issues and audits.

85 Strong knowledge and experience of ISO13485 and FDA audit.

85 In-depth understanding of quality management principles and methodologies (e.g., Lean, Six Sigma, 8D, FMEA, PPAP). Certifications such as Six Sigma Black Belt or Green Belt are advantageous.

85 Excellent analytical and problem-solving skills with the ability to interpret data and implement effective solutions.

85 Strong leadership and team management skills with the ability to motivate and develop team members.

85 Excellent communication (written and verbal in English) and interpersonal skills to effectively interact with all levels of the organization, customers, and suppliers.

Job Responsibilities:

1. Oversee the implementation of quality control plans throughout the manufacturing process (NPI + MP) and quality performance at customer site.

2. Establish and monitor key quality indicators (KPIs) to track and improve process performance and product quality (e.g., defect rates, yield, FPY: 首件通过率).

3. Analyze quality data, identify trends, and implement corrective and preventive actions (CAPA) to address quality issues.

4. Ensure proper handling and disposition of non-conforming products. Participate in process improvement teams to enhance efficiency, reduce waste, and improve quality. Implement and monitor the effectiveness of corrective and preventive actions.

5. Manage customer complaints, conduct investigations, and implement appropriate corrective actions. Participate in customer quality audits and visits. Ensure customer quality requirements are understood and met.