Quality Engineer

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

Develops and implements quality control systems, inspects and tests products, and analyzes data to ensure products meet safety and quality standards such as ISO13485, Medical Device Regulation 2017/745 (EU MDR), 93/42/EEC, MSDAP and the US Code of Federal Regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential duties and responsibilities include the following. Other duties may be assigned.

• Review and Analysis Review and analyze requirements, specifications, and design documents to ensure full test coverage for lot release
• Test Planning Create comprehensive test planning documents for existing and new products
• Automation Develop and implement performance criteria for testing equipment and in process testing to meet specification requirements
• Defect Management Identify and documentdefects and evaluate improvements for changes to improve compliance with specifications and standards
• Documentation Maintain detailed records of all testing including defects
• CAPA Utilize the Quality System to ensure CAPA system is successful and compliant
• Document Control Responsible for Document Control of existing procedures and records, ensuring compliance with all applicable Standards and Requirements
• Auditing Internal and supplier audit training for EUMDR and ISO 13485
• Lot Release Review and ensure compliance in releasing and verifying DHR Lot release
• Data Analysis: Use statistical analysis and various software to analyze complex data and make data-driven decisions
• Provides QA support during third party audits
• Identifies deadlines and implements methods to comply with responsibilities in a timely fashion
• Ability to get along with others, follows directions, and works well under stressful conditions
• Responsible for following company policies and procedures, including but not limited to, Quality System Regulations, safety/housekeeping, and Quality Management System.