Senior Quality Manager — ISO 9001 & FDA Compliance

EssilorLuxottica

Mariveles

On-site

PHP 900,000 - 1,300,000

Full time

10 days ago

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Job summary

EssilorLuxottica is seeking a Quality Manager to lead the quality system and ensure compliance with ISO 9001 and regulatory mandates. You will drive process improvement and collaborate with cross-functional teams to uphold high standards across products and services.

The role requires a B.S. in engineering or science, 5+ years ISO experience, fluency in English, and strong problem-solving skills to implement 8D/QRQC methodologies and CAPA.

Qualifications

  • B.S. Engineering or Scientific degree or related fields.
  • Knowledge in QA concepts such as TQM, problem solving, SPC & QA tools (8D, FTA, Ishikawa), Risk Assessment, and FMEA.
  • 5+ years with ISO standards; ISO training/certification; MOC, Risk Assessment, CAPA, and Customer Complaint handling.
  • Above average written communication skills; fluency in English is a must.
  • Strong drive and ability to influence others.

Responsibilities

  • Ensure the organization's processes, products, and systems comply with ISO 9001 and regulatory mandates.
  • Create and maintain a Quality Management System (QMS) to support continuous improvement and efficiency.
  • Implement quality standards and ensure products meet specifications.
  • Collaborate with other departments to conduct root cause analysis using 8D/QRQC.
  • Assess product specs to meet customer requirements.
  • Oversee processes to improve capability and consistency of quality.
  • Ensure FDA CMDN compliance.

Skills

Quality Assurance
Total Quality Management
Problem Solving
SPC
Quality Tools
8D
FTA
Ishikawa
Risk Assessment
FMEA

Education

B.S. Engineering

Job description

EssilorLuxottica is seeking a Quality Manager to lead the quality system and ensure compliance with ISO 9001 and regulatory mandates. You will drive process improvement and collaborate with cross-functional teams to uphold high standards across products and services.

The role requires a B.S. in engineering or science, 5+ years ISO experience, fluency in English, and strong problem-solving skills to implement 8D/QRQC methodologies and CAPA.

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