QA Engineer ISO

Overview

Job Title: QA Engineer with ISO
Location: Georgetown
Employment Type: Full-Time
Department: Quality

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.

• 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.

• 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)