Quality Assurance Technician

Job Title:

Quality Assurance Technician

Job Description

The Quality Assurance Technician supports the design, creation, implementation, and monitoring of quality programs and methodologies to ensure products consistently meet established specifications, design criteria, quality standards, and customer requirements. This role focuses heavily on Device History Record (DHR) review for instrument manufacturing operations and supports the product release function by reviewing device history and batch records for compliance with internal procedures and regulatory expectations.

The technician helps ensure all requirements for product release are met while contributing to increased throughput and efficiency in the product release department.

Responsibilities

* Review Device History Records (DHRs) for instrument manufacturing operations to ensure accuracy, completeness, and compliance with internal procedures and regulatory standards.

* Support the product release department by reviewing device history and batch records to verify that all release criteria and quality requirements are met before shipment.

* Identify discrepancies, errors, or nonconformances in documentation and records, and ensure appropriate corrective actions are taken prior to product release.

* Communicate issues found during DHR and batch record reviews to production and other relevant teams on the manufacturing floor, clearly explaining required corrections.

* Collaborate with cross-functional teams to negotiate and agree on corrective actions and timelines needed to resolve identified issues.

* Participate in the implementation and monitoring of quality programs and methodologies that support compliance with FDA-regulated requirements and Good Manufacturing Practices (GMP).

* Contribute to metrics tracking systems by providing data on the number of records reviewed, types of errors found, and trends in quality issues.

* Support continuous improvement activities by highlighting recurring issues and recommending process or documentation improvements.

* Assist with quality assurance activities related to CAPA (Corrective and Preventive Actions) and audits as needed.

* Adapt to a fast-paced environment by managing multiple priorities and switching between tasks quickly while maintaining attention to detail.

Essential Skills

* At least 1 year of experience in a manufacturing environment.

* At least 1 year of experience in a quality-focused role (Quality Assurance preferred, but Quality Control experience will be considered).

* Experience working in an FDA-regulated environment such as pharmaceutical, medical device, or biotechnology manufacturing.

* Working knowledge of quality assurance principles, including CAPA and audit practices.

* Familiarity with Good Manufacturing Practices (GMP).

* Strong computer skills, including proficiency with Microsoft Windows and Microsoft Office programs.

* Ability to work effectively in a fast-paced environment and switch between tasks quickly while maintaining accuracy.

* Strong verbal and written communication skills to clearly convey issues and required actions to production and other teams.

* High attention to detail and strong documentation review skills.

Additional

Skills & Qualifications

* Associate's degree in engineering or a life science discipline is preferred.

* Experience using Oracle or similar enterprise systems.

* Certification in a quality discipline such as CQT (Certified Quality Technician), CCT (Certified Calibration Technician), or CQI (Certified Quality Inspector) is a plus.

* At least 1 year of experience participating in formal audits is desirable.

* Experience tracking and reporting quality metrics or performance indicators.

* Demonstrated ability to collaborate with cross-functional teams to resolve quality issues.

Work Environment

This position operates in a regulated manufacturing environment that supports pharmaceutical, medical device, or biotechnology production. The role is primarily office and production-floor based, with frequent interaction with manufacturing teams and quality personnel. Standard work hours are typically 8:00 AM to 5:00 PM, with flexibility to work 7:00 AM to 4:00 PM or 9:00 AM to 6:00 PM as needed. The environment is fast paced, with a strong focus on accuracy, compliance, and meeting product release timelines.

Work is performed using standard office software such as Microsoft Windows and Office, and may include use of Oracle or similar systems for documentation and data tracking. The culture emphasizes continuous improvement, collaboration, and professional growth, with a high possibility of contract extension and potential conversion to a longer-term role based on performance.

Job Type & Location

This is a Contract to Hire position based out of Austin, TX.

Pay and Benefits

The pay range for this position is $20.00 - $25.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to…