Onsite Irvine — Supplier Quality Engineer, Medical Devices

Intellectt Inc; California (MO); On-site; USD 80,000 - 100,000; Full time

Job summary

A medical device company is seeking a Supplier Quality Engineer for a 12-month contract. This mid-senior level role involves leading supplier qualification and ensuring compliance with FDA and ISO standards. The engineer will conduct audits, monitor supplier performance, and drive quality improvements using Lean/Six Sigma techniques. The position is based in Irvine, CA, offering an opportunity to work on complex Class II/III medical devices.

Qualifications

• Experience in support of supplier qualification for medical devices.
• Ability to lead supplier audits and investigations.
• Strong understanding of FDA regulations and quality standards.

Responsibilities

• Lead supplier part qualification for product launch.
• Execute capability studies and process validations.
• Conduct supplier audits and monitor compliance.

Skills

Supplier quality assurance

Process validation

Statistical analysis

Lean/Six Sigma techniques

Job description

A medical device company is seeking a Supplier Quality Engineer for a 12-month contract. This mid-senior level role involves leading supplier qualification and ensuring compliance with FDA and ISO standards. The engineer will conduct audits, monitor supplier performance, and drive quality improvements using Lean/Six Sigma techniques. The position is based in Irvine, CA, offering an opportunity to work on complex Class II/III medical devices.