QA Engineer - Medical Devices, ISO 13485, Six Sigma

Sanmina Corporation; Kenosha (WI); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading integrated manufacturing solutions provider is seeking a QA Engineer 3 to ensure products exceed customer expectations. This role involves quality engineering, conducting audits, and ensuring compliance with ISO 13485. Qualifications include a Bachelor’s degree, at least 5 years of experience in a manufacturing environment, preferably in the medical device field, and familiarity with core medical tools. Strong problem-solving and organizational skills are essential for success in this role.

Qualifications

• 5+ years of experience in a manufacturing environment, preferably in the medical device industry.
• Solid experience with medical core tools like PFMEA, Control Plans, SPC, MSA.
• Able to define and interpret problems, collect data, and draw conclusions.

Responsibilities

• Lead quality planning activities for new product release projects.
• Provide validation, sampling, and statistical analysis support.
• Interface closely with operations, manufacturing, and program management.

Skills

Problem solving using root cause methodologies

Applying statistics and software in data analysis

Application of failure modes and effects analysis (FMEA)

Excellent organizational and communication skills

Flexibility for handling a wide range of activities

Ability to work under pressure

Education

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

5+ years Quality Engineering experience

ASQ Certification as a Quality Engineer or Six Sigma Green/Black Belt

Tools

ISO 13485

Lean/Six Sigma methodologies

Job description

A leading integrated manufacturing solutions provider is seeking a QA Engineer 3 to ensure products exceed customer expectations. This role involves quality engineering, conducting audits, and ensuring compliance with ISO 13485. Qualifications include a Bachelor’s degree, at least 5 years of experience in a manufacturing environment, preferably in the medical device field, and familiarity with core medical tools. Strong problem-solving and organizational skills are essential for success in this role.