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Qms Engineer

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OPSM

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Location:
Thailand , Chonburi

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

This role will take the lead of Essilor Luxottica global quality system CAPAs (From Audits, Inspections, Others…) process globally to ensure the sustainability and the effectiveness of the global QMS. Support the needs of QMS Global audit program. Strong focus on Software Validation compliance ensuring sustained regulatory compliance, audit readiness and business continuity across global operations. Support the improvement and adjustment of Global QMS and Global standards for an effective deployment and continuous compliance to new regulations and or business needs or organization transformation.

Job Responsibility:

  • Lead the Global QMS CAPAs process and driving cross-function on global problems solving and process improvement related to quality system to ensure effective and sustainable quality practices
  • Acts as Subject Matter Expert (SME) for Software Validation, supporting the design, implementation and continuous improvement of global Software Validation process in alignment with ISO 13485, GMP and applicable regulatory expectations
  • Ensure Software Validation compliance is embedded into QMS processes, recognizing its critical role in audit readiness, regulatory inspections and operational continuity
  • Continue the maintenance and effectiveness of QMS implementation based on Essilor Luxottica Group Quality System and related quality standard requirement
  • Organize and perform quality audits to assess compliance and identify areas for improvement, ensuring readiness for audits by Certification Bodies and competent Authorities and ensure quality system comply with Essilor Luxottica group quality system and related quality standard requirement
  • Follow up, monitor CAPAs WW (CAPAs from global Audits, Certification Audits, Competent Authorities Inspections, etc.), and leverage effective solutions for global deployment
  • Promote and establish a continuous improvement culture by initiate and leading global quality project to enhance and harmonize QMS workflows in alignment with Medical Device Regulations, and promote the culture of “Find it once, fix it everywhere”
  • Collaborate with global stakeholders to embed quality into core operations and drive strategic alignment across each area and functions.

Requirements:

  • Bachelor / Master degree in Engineering or Science in the field of Chemistry / Material / Industrial / Physical / Electrical / Mechanical or its equivalent
  • Knowledge of quality system minimum requirement but not limit to: ISO13485, ISO9001, GMP and ISO14971
  • Enrich with quality mindset in Medical Devices or Healthcare environment and have systematic and logical thinking
  • Solid knowledge of Quality system (Document control, Quality audit, Management of change, Risk management, Software Validation and computerized systems compliance within a regulated environment, CAPA)
  • 3-5 year of working experience in Essilor Luxottica or Globally organization is advantage
  • Project management skills and know- how will be an advantage
  • Proficient in MS Applications (Excel, Word, PowerPoint, SharePoint, Visio)
  • Proficient in English (read, write, speak) and may require to travel in the zone around 10-20%
  • Non-technical skill required
  • leadership, organization skills, clear and effective communication, logical thinking, action and result oriented ability to animate and mobilize the teams.

Additional Information:

Job Posted:
April 12, 2026

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