QA Engineer with ISO

Georgetown, TX
Full Time
Mid Level
Job Title: QA Engineer with ISO  
 Location: Georgetown
Employment Type: Full-Time
Department: Quality
Position Summary:
The Quality Engineer will ensure that products, processes, and systems meet established quality standards, with a strong emphasis on ISO compliance. This role supports continuous improvement initiatives, conducts audits, analyzes data, and collaborates with cross‑functional teams to maintain and elevate product quality.
Key Responsibility:
  • Maintain and improve the company’s Quality Management System (QMS) in alignment with ISO standards (e.g., ISO 9001, ISO 13485, or ISO/TS 16949 depending on industry).
  • Lead internal ISO audits and support external certification audits.
  • Develop, revise, and implement quality procedures, work instructions, and documentation.
  • Conduct root cause analysis and implement corrective and preventive actions (CAPA).
  • Perform process capability studies and statistical analysis to identify improvement opportunities.
  • Collaborate with engineering, production, and supply chain teams to resolve quality issues.
  • Develop inspection plans, testing protocols, and acceptance criteria.
  • Oversee incoming, in‑process, and final inspection activities.
  • Ensure calibration and maintenance of measurement and test equipment.
  • Lead Lean, Six Sigma, or Kaizen initiatives to reduce defects and improve efficiency.
  • Monitor quality KPIs and prepare reports for leadership.
  • Evaluate and monitor supplier performance.
  • Conduct supplier audits and support supplier development activities.
Qualifications:
  • Bachelor’s degree in Engineering or related field
  • ISO certification (ISO 9001 Lead Auditor, ISO 13485, or similar)
  • 5 years of experience in quality engineering or quality assurance
  • Strong knowledge of QMS, SPC, FMEA, CAPA, and root‑cause methodologies
  • Proficiency with quality tools (e.g., Minitab, control charts, PPAP, APQP)

 
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