Save Job Back to Search Job Description Summary Similar JobsBuild a world-class quality system for a growing electronics device plant.Lead strategic quality initiatives with global business exposure.About Our ClientA global electronics and medical device company dedicated to developing and manufacturing innovative electronics devices. The organization combines advanced manufacturing capabilities, strict quality standards, and a commitment to regulatory excellence while fostering a collaborative and growth-oriented work environment.Job DescriptionEstablish, implement, and maintain the Quality Management System (QMS) to ensure compliance with applicable regulations and standards, including TFDA, US FDA 21 CFR 820, EU regulations, and ISO 13485.Lead the development and continuous improvement of quality systems for a medical device manufacturing facility.Oversee routine quality control operations to ensure products consistently meet regulatory, customer, and company quality requirements.Act as the site quality representative and ensure compliance with all applicable quality and regulatory requirements.Support product transfer projects to ensure timely execution while meeting quality, compliance, and business objectives.Support new product introduction (NPI), localization, and manufacturing change projects to ensure successful implementation and regulatory compliance.Build, lead, and develop the Quality team through recruitment, coaching, training, and performance management.Collaborate with cross-functional teams to qualify, develop, and monitor supplier performance.Serve as the primary contact for customers on quality-related matters, including complaints, deviations, product transfers, and quality performance reviews.Manage the calibration program to ensure equipment accuracy and compliance.Lead customer audits, regulatory inspections, and third-party certification audits.Establish and manage validation systems, including validation planning, execution, monitoring, and maintenance activities.Drive continuous quality improvement initiatives across manufacturing and operational processes.Promote a Quality First culture through training, awareness programs, and day-to-day leadership.Escalate significant quality issues and provide recommendations to senior management.Support additional assignments and strategic quality initiatives as required.The Successful ApplicantBachelor's degree or higher in Engineering or in a related technical discipline.Minimum 10 years of experience in quality management within the electronics, healthcare industry, or in medical device manufacturing.Strong experience in establishing, implementing, and maintaining Quality Management Systems.Strong understanding in regulations and standards, including TFDA, US FDA 21 CFR 820, EU regulations, and ISO 13485.Familiar with clean room working environment.Proven experience leading quality teams and managing quality-related functions.Experience supporting product transfer, technology transfer, or manufacturing expansion projects is preferred.Knowledge of regulatory requirements, quality standards, and certification processes, including ISO and health authority approvals.Experience managing audits, inspections, validation systems, and supplier quality programs.Strong leadership, communication, and stakeholder management skills.High level of integrity with the ability to manage and communicate sensitive quality issues.Strong problem-solving and decision-making capabilities.Fluent in Thai and English, both written and spoken.What's on OfferBuild a world-class quality system for a growing medical device plant.Lead strategic quality initiatives with global business exposure.ContactNantipat PongsirikunQuote job refJN-082025-6812517Phone number+6620125001Job summarySectorEngineering & ManufacturingSpecialisationQuality, TechnicalWhat is your area of specialisation?Industrial / ManufacturingLocationChonburi ProvinceContract TypePermanentConsultant nameNantipat PongsirikunConsultant phone+6620125001Job ReferenceJN-082025-6812517
