Quality Assurance Technician

Job Title:

Quality Assurance Technician

Job Description

The Quality Assurance Technician plays a key role in designing, implementing, and monitoring quality programs and methodologies to ensure that 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.

The technician ensures that all requirements for product release are met and helps increase throughput for the product release department in a fast-paced, regulated manufacturing environment.

Responsibilities

* Participate in the design, creation, implementation, and monitoring of quality programs and methodologies to ensure products meet specifications, design criteria, and quality standards.

* Review Device History Records (DHR) for instrument manufacturing operations to verify completeness, accuracy, and compliance with internal procedures and regulatory requirements.

* Support the product release department by reviewing device history and batch records for adherence to internal procedures and quality standards.

* Verify that all requirements for product release are met before authorizing release of finished products.

* Identify discrepancies, errors, or nonconformances in documentation and records, and ensure they are addressed in a timely manner.

* Communicate identified issues to production floor personnel and other stakeholders, clearly explaining problems and required corrections.

* Collaborate with cross-functional teams to seek out corrections, negotiate appropriate actions, and ensure effective resolution of quality issues.

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

* Support continuous improvement initiatives by highlighting recurring issues and suggesting improvements to processes, documentation, and controls.

* Operate effectively in a fast-paced environment, managing shifting priorities and switching between tasks quickly while maintaining high attention to detail.

* Assist with preparation for audits and inspections by ensuring documentation and records are complete, accurate, and readily accessible.

* Participate in or support formal audits as needed, helping demonstrate compliance with internal procedures, Good Manufacturing Practices (GMP), and regulatory requirements.

* Use computer systems and software, including Microsoft Windows and Office programs, to document findings, maintain records, and generate reports.

* Adhere to Good Manufacturing Practices (GMP) and quality system requirements in all daily activities.

Essential Skills

* Quality assurance experience in an FDA-regulated environment such as pharmaceutical, medical device, or biotechnology manufacturing.

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

* At least 1 year of experience in a quality function (Quality Assurance preferred, but Quality Control experience may be considered).

* Hands-on experience with quality assurance activities such as CAPA (Corrective and Preventive Actions) and audits.

* Strong understanding of Good Manufacturing Practices (GMP) and regulatory expectations in an FDA-regulated setting.

* Proficiency with computer systems, including Microsoft Windows and Office programs (such as Word, Excel, and Outlook).

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

* Strong communication skills, with the ability to clearly convey issues, required corrections, and expectations to production floor personnel and other stakeholders.

* Ability to interpret and review device history records, batch records, and related documentation for compliance and completeness.

* Capability to track and report metrics related to record reviews and error trends.

Additional

Skills & Qualifications

* Associate's degree in engineering, life science, or a related field is preferred.

* Experience using Oracle or similar enterprise systems for data entry, tracking, or documentation management.

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

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

* Experience working in a product release or documentation review role within a regulated manufacturing environment.

* Demonstrated ability to support continuous improvement initiatives by identifying trends and recommending process enhancements.

* Strong organizational skills and the ability to manage multiple priorities and deadlines.

* Comfort working with metrics and data to monitor performance and identify issues.

Work Environment

This role is based in a regulated…