QA Engineer - Medical Devices | ISO 13485

SANMINA-SCI TECHNOLOGY INDIA PRIVATE LIMITED; Wisconsin; On-site; USD 80,000 - 110,000; Full time

Job summary

Sanmina Corporation is seeking a QA Engineer in Wisconsin to provide quality engineering and assurance for products and processes, ensuring compliance with ISO 13485 and related standards. You will lead quality planning, audits, and cross-functional collaboration across operations, engineering, and program management.

The role requires 5+ years of quality engineering in manufacturing, experience with PFMEA, Control Plans, SPC and MSA, and Lean/Six Sigma.

Qualifications

• Bachelor's Degree in Electrical, Electronic, Industrial Engineering or similar
• 5+ years Quality Engineering experience in manufacturing
• Experience with ISO 13485 and ISO 9001/TL9000
• Experience with medical core tools PFMEA, Control Plans, SPC, MSA
• Lean/Six Sigma implementation experience preferred
• Ability to define and interpret problems, collect data, establish facts
• Excellent communication with coworkers, customers, and suppliers
• Familiar with industry standards, drawings, specifications
• Knowledge of problem-solving and quality improvement tools and techniques
• ASQ Certification as a Quality Engineer or Six Sigma Belt desired

Responsibilities

• Lead quality planning activities for new product release projects including verification and 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 to other functions
• Provide day-to-day quality engineering support for specific customer programs
• Interface with operations, manufacturing, test engineering and program management
• Wear responsibility for customer product and process quality including continual quality improvement and CAPA responses
• Utilize Six Sigma methodologies for process improvement

Skills

Root cause analysis

Statistical analysis

Quality tooling

Communication

Organizational skills

Problem solving

Cross-functional collaboration

Process improvement

Education

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

Tools

PFMEA

Control Plans

SPC

MSA

Job description

Sanmina Corporation is seeking a QA Engineer in Wisconsin to provide quality engineering and assurance for products and processes, ensuring compliance with ISO 13485 and related standards. You will lead quality planning, audits, and cross-functional collaboration across operations, engineering, and program management.

The role requires 5+ years of quality engineering in manufacturing, experience with PFMEA, Control Plans, SPC and MSA, and Lean/Six Sigma.