PQE Leader-Medical

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Job Summary

To support our extraordinary teams who build great products and contribute to our growth were looking to add a Product Quality Engineer Leader located in Suzhou SIP

Reporting to the Sr. Quality Manager the PQE Leader role involves..

What a typical day looks like:

• Ensure product quality and process quality control to meet customer requirements.
• Work with customers for any major quality issue.
• /Follow up with customer audit and/or the 3rd party audit.
• //Manage product quality engineers and/or quality technicians and/or quality assurance to perform below actions:
• . SPC Control Quality Inspection and Post Pack Audit.
• /Prepare quality reports/documents and establish quality improvement program.
• Conduct regular quality review meetings with other relevant departments.
• Resolve customer returns and review the quality performance regularly.
• Handle customer complaints and drive the relevant departments to take actions.
• Handle corrective actions to resolve any problems in the manufacturing process which can cause quality or potential quality problems.
• Initiate working instructions of Quality Inspection and Post Pack Audit.

The experience were looking to add to our team:

• College or above
• 5EMS2Minimum 5 yearsworking experience in EMS company in which 2 yearsexperience in managerial position.
• IPC-A-610Be trained in quality tools and techniques such as SPC FMEA Control Plan CAPA and IPC-A-610.
• (YY/T0287/ISO13485) Have experience or knowledge of medical device quality management system requirements (e.g. YY/T0287/ISO13485 or equivalent) is preferred.
• Be trained in medical quality system statistical process control and technical management.
• Fluent communication and presentation skills in English.

What youll receive for the great work you provide:

• Social Insurance
• Life Insurance
• PTO

Job Category

Required Skills:

Optional Skills:

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit qualifications and abilities. We do not discriminate based on: age race religion color sex national origin marital status sexual orientation gender identity veteran status disability pregnancy status or any other status protected by law. Were happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and well discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex you must complete the application process first).