QA Engineer - Quality & Process Improvement (ISO 13485)

Sanmina; Carrollton (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Sanmina Corporation is seeking a QA Engineer in Texas to provide quality engineering and assurance, ensuring products and services exceed customer requirements. You will collaborate across functions to keep the Quality Management System compliant with ISO 13485 and related standards.

Responsibilities include leading quality planning for new product releases, supporting validation, audits, and data-driven improvement. Strong communication with operations and program management is essential.

Qualifications

• Bachelor's degree in engineering or related field is required.
• 5+ years Quality Engineering experience in manufacturing, preferably medical devices.
• Solid knowledge of ISO 13485 and other QMS (ISO 9001, TL9000).
• Experience with core tools e.g., PFMEA, Control Plans, SPC, MSA; validation knowledge.
• Lean/Six Sigma implementation experience preferred.
• ASQ Quality Engineer or Six Sigma certification desired.

Responsibilities

• Lead quality planning for new product releases, including verification/validation plans.
• Contribute to validation planning for new and existing processes.
• Initiate or assist in cost reductions of product inspections.
• Ensure effective product engineering control and transfer to production.
• Provide validation, sampling, and statistical analysis support.
• Maintain ISO 13485 compliant systems and processes.
• Provide day-to-day quality engineering support for customer programs.
• Interface with operations, manufacturing, test engineering, and program management.
• Own quality metrics including risk analysis, CAPA, corrective actions.

Skills

Quality engineering

ISO 13485 knowledge

Six Sigma

PFMEA & Control Plans

Statistical analysis

Root cause analysis

Education

Bachelor's degree in Electrical, Electronic, Industrial Engineering or similar

Tools

MS Excel

Minitab

CAPA system

Job description

Sanmina Corporation is seeking a QA Engineer in Texas to provide quality engineering and assurance, ensuring products and services exceed customer requirements. You will collaborate across functions to keep the Quality Management System compliant with ISO 13485 and related standards.

Responsibilities include leading quality planning for new product releases, supporting validation, audits, and data-driven improvement. Strong communication with operations and program management is essential.