Job Title: Quality Assurance Technician

Job Description

The Quality Assurance Technician plays a crucial role in ensuring that company products meet established specifications, design criteria, quality standards, and customer requirements. This position involves participation in the design, creation, implementation, and monitoring of programs and methodologies. The primary focus is supporting the product release department by reviewing device history and batch records for compliance with internal procedures, ensuring the requirements for product release are met and enhancing throughput for the department.

Responsibilities

• Review device history and batch records for compliance with internal procedures.
• Ensure requirements for product release are met.
• Monitor and enhance throughput for the product release department.
• Provide information for metrics tracking systems, reporting on reviews and errors found.
• Communicate issues to the production floor and negotiate necessary corrective actions.
• Participate in formal audits and ensure compliance with FDA regulations.

Essential Skills

• Experience in quality assurance, CAPA, and audit processes.
• Experience in FDA-regulated environments, such as pharmaceuticals, medical devices, or biotechnology.
• At least 1 year of experience in a manufacturing environment, preferably in a QA role.
• At least 1 year of experience participating in formal audits.
• Proficiency in computer skills, including Microsoft Windows and Office programs.

Additional Skills & Qualifications

• Preferred Associate's Degree in engineering or life science.
• Experience with Oracle systems.
• Certification in quality disciplines such as CQT, CCT, CQI.

Work Environment

The work environment offers flexible hours, typically from 8AM to 5PM, but can be adjusted to 7AM to 4PM or 9AM to 6PM. There is a high possibility of extension and potential conversion, making this an attractive opportunity for career growth.