Johnson Electric Senior Medical Device Quality Engineer 

China, Guangdong Province, Jiangmen 

313151836

This candidate will support all aspects of the Quality Assurance (QA) program within the Quality Management System (QMS). The QE reports to the Q&R Manager. This position will lead all customer and third-party quality audits. Participate in Design Project Teams as a QE/QA Representative to ensure that input requirements (internal, external, and customer) are clearly defined, risk assessment is performed, output meets input requirements, and objective evidence clearly supports conclusions. Perform quality related design control activities as assigned by Design Project Team. Partner with production during Design Transfer phase to ensure that products and processes meet all quality requirements.

Your responsibilities will be:

• Ensure customer and regulatory requirements are met along the product development cycle.

• Develop and implement medical quality system per ISO13485 and customer requirements. Create production, calibration, inspection, and maintenance procedures as required.

• Use Failure Modes Effects Analysis (FMEA), Fault Tree Analysis (FTA), Fish Bone Diagram, Risk Analysis, or other appropriate quality tools to define and manage risk or identify root cause of failure.

• Assist and/or complete with the resolution of quality issues related to non-conformance reports, customer complaints, regulatory actions, etc. Support CAPA investigations and related corrective and preventive actions.

• Assist in development, review and approval of process and equipmentvalidation/qualifications(IQ, OQ, PQ). Develop, review, and improve inspection plans, standard work sheet and product drawings.

• Work on continuous improvement activities. Support Kaizen activities and re-work/scrap reduction.

• Develop and implement quality management systems compliant with FDA regulations.

• Conduct CPK (Process Capability Index) analysis to evaluate process performance and product consistency.

• Lead root cause analysis and implement corrective actions for product and process issues.

• Collaborate with cross-functional teams to ensure quality throughout the product lifecycle.

• Design and execute validation protocols for new processes and equipment.

• Monitor and report on quality metrics, trends, and performance.

• Provide training and support to staff on quality assurance processes and FDA compliance.

Basic Qualifications:

• Bachelor’s degree in engineering, Quality Assurance, or related field.

• 3+ Years Quality Experience within in Medical Device Manufacturing

• Extensive knowledge of FDA regulations, including 21 CFR Part 820 AND ISO13485

• Proficiency in equipmentvalidation/qualifications(IQ, OQ, PQ)

• Proficiency in statistical analysis and understanding of CPK and other quality metrics.

• Strong problem-solving skills using FMEA, FTA methodology

• Ability to navigate and performing cross-functional teams.

• Excellent communication and interpersonal skills.

What We offer:

JE offers talented employee’s exceptional opportunities to learn and grow professionally with rewarding careers. We offer a competitive benefits package including medical, dental, prescription plan, vision, disability coverage, life insurance coverage, 401K match, and holiday/vacation benefits.