Quality Engineer - Medical Devices, ISO 13485 & MDR

Retractable Technologies, Inc.; Little Elm (TX); Hybrid; USD 85,000 - 115,000; Full time

Job summary

Retractable Technologies, Inc. is seeking a QA/QC professional to develop and implement quality control systems, inspect products, and analyze data to ensure safety and compliance with ISO 13485, EU MDR, and US CFR 21 Part 820.

You will review requirements, create test plans, manage defects, and support audits with a focus on CAPA and documentation. The role requires a Bachelor’s degree and 2–5 years in medical device quality assurance; Six Sigma Black Belt preferred; bilingual in

Qualifications

• Bachelor’s degree required.
• 2–5 years of related work experience in medical devices or quality assurance.
• Six Sigma Black Belt preferred; CAPA navigation in Quality System.

Responsibilities

• Review requirements, specifications, and design documents to ensure test coverage.
• Create comprehensive test plans for existing and new products.
• Develop testing criteria for equipment and in-process testing to meet specs.
• Document defects and track improvements to ensure compliance with standards.

Skills

Quality assurance

Analytical skills

Project management

English language proficiency

Spanish language (a plus)

Education

Bachelor’s degree

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

Job description

Retractable Technologies, Inc. is seeking a QA/QC professional to develop and implement quality control systems, inspect products, and analyze data to ensure safety and compliance with ISO 13485, EU MDR, and US CFR 21 Part 820.

You will review requirements, create test plans, manage defects, and support audits with a focus on CAPA and documentation. The role requires a Bachelor’s degree and 2–5 years in medical device quality assurance; Six Sigma Black Belt preferred; bilingual in