Medical Device QA Engineer: Compliance & Data Analysis

Retractable Technologies, Inc; Little Elm (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

Retractable Technologies, Inc. is seeking a Quality Assurance professional to develop and implement QC systems for medical devices. You will review requirements, plan tests, automate checks, and manage CAPA, document control, and audits to ensure compliance with ISO13485 and MDR standards.

The role requires analyzing data, releasing lot documentation, and supporting third-party audits while maintaining quality and safety in a fast-paced environment.

Qualifications

• Experience with ISO 13485, EU MDR, 93/42/EEC, MDSAP and US CFR.
• Strong data analysis and test planning capabilities.
• Experience with CAPA and document control.

Responsibilities

• Review requirements and designs to ensure test coverage for lot release.
• Create comprehensive test plans for existing and new products.
• Develop performance criteria for testing equipment and processes.
• Identify defects and drive improvements for compliance.
• Maintain detailed records of testing and defects.
• Ensure CAPA processes are followed and compliant.
• Control documents and records per standards.
• Support internal and supplier audits for MDR and ISO 13485.
• Review and verify DHR lot release.
• Use data analysis to drive decisions.
• Support QA during third-party audits.
• Meet deadlines and work under pressure.
• Adhere to quality system and safety policies.

Skills

Test planning

Automation

Data analysis

Documentation

CAPA

Auditing

Lot release

Teamwork

Tools

Statistical software

Job description

Retractable Technologies, Inc. is seeking a Quality Assurance professional to develop and implement QC systems for medical devices. You will review requirements, plan tests, automate checks, and manage CAPA, document control, and audits to ensure compliance with ISO13485 and MDR standards.

The role requires analyzing data, releasing lot documentation, and supporting third-party audits while maintaining quality and safety in a fast-paced environment.