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Senior Quality Engineer

Kimball Electronics (Thailand) Ltd. (Chon Buri)
Chonburi, Thailand 🇹🇭
Kimball Electronics is a global, multifaceted manufacturing solutions provider recognized for its reputation of excellence. We are committed to a high-performance culture that values personal and organizational commitment to quality, reliability, value, speed, and ethical behavior. Kimball Electronics provides end-to-end engineering, design and manufacturing solutions, including contract Electronics Manufacturing Services (EMS), Diversified Contract Manufacturing Services (DCMS), and Automation, Test & Measurement services to customers in the automotive, medical, and industrial end markets. We deliver award-winning service through our highly integrated global footprint, stringent quality systems, customer relationship management model, and supply chain support.

About this position

The Senior Quality Engineer is responsible for ensuring compliance with regulatory, QMS, and customer requirements, maintaining quality standards, and facilitating communication across functions to drive continuous improvement.

Responsibilities

• Reviews regulatory, QMS and customer requirements to ensure compliance and meet the requirements.
• Ensure the quality of product and process to meet with the regulation and customer’s requirement.
• Maintain audit programs and Management review and provide reporting results to management.
• Participates in internal, external, customer audits (and regulatory inspections).
• Maintain Complaint file and Corrective action & Preventive action system.
• Maintain Process Validation activities.
• Facilitate communication between functions, multi-facility groups and customers.
• Resource review.
• Pursue team in organization for Continuous improvement.

Requirements

• Bachelor degree or higher in Engineering field or equivalent industry experience.
• A minimum of 10 years of experience in the Quality function.
• Experience for both of Quality Assurance engineer (In process/product and customer quality) and Quality Management System in electronics manufacturing.
• Experience in PCBA or complete medical device will be advantageous.
• Knowledge of FDA Quality System Requirements 21CFR820, 21CFR PART11, ISO 13485, ISO 14971 and Medical Process validation IQOQPQ will be advantageous.
• Ability to manage small projects/programs with limited assistance from others.
• Certified Internal Auditor.
• Ability to use Microsoft Office and email.
• Leadership skills including ability to maintain confidentiality.
• Knowledge and ability to be a consultant of Corrective action & Preventive action program base on 8D methodologies.
• Ability for communication, teamwork and organizational skills to carry out projects to meet timelines.
• Decision making and prioritization skills.
• Good English communication.