Quality Engineering Technician

Neuralink•Austin, TX

9d•Onsite

About The Position

The Quality Engineering Technician will execute and support equipment quality, calibration, maintenance, troubleshooting, verification and validation (V&V), and process and equipment qualification activities across R&D, preclinical, and manufacturing. Responsibilities include: Calibrate, perform preventive maintenance, troubleshoot, and repair instruments, devices, and equipment in the quality program (including biomedical devices, industrial instrumentation, lasers, RF systems, and related technologies) with little to no supervision, ensuring accuracy, reliability, and compliance. Assist in the check-out, start-up, installation, acceptance, and commissioning of new or modified equipment; support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities; determine and requisition parts required for maintenance and repairs. Execute and document verification and validation activities for engineering work, processes, and equipment, including following or supporting protocols, collecting data, recording results, investigating deviations, and maintaining traceability. Adhere to cGxP guidelines, SOPs, safety rules/regulations, and quality system requirements; apply good documentation practices and clearly explain technical issues, calibration processes, and V&V/qualification results to cross-functional peers and stakeholders. Collaborate with engineering, quality, manufacturing, and other teams to resolve equipment and quality issues, support root-cause analysis, and drive timely closure; contribute to continuous improvement of equipment quality processes, procedures, templates, and workflows. Support change control and related quality activities for equipment and processes by providing accurate data, documentation, and technician-level input; maintain accurate equipment records and calibration status. Some travel may be required.

Requirements

Ability to comprehend and apply technical manuals, schematics, and procedures for calibration, maintenance, troubleshooting, testing, and qualification activities.
Strong attention to detail and ability to work accurately, independently, and effectively in a dynamic, fast-paced, regulated environment while managing multiple priorities.
Strong interpersonal and communication skills; ability to collaborate professionally with cross-functional teams and explain technical issues clearly in an organized manner.
Basic understanding of quality systems, documentation practices, and regulated (e.g., cGxP) environments.

Nice To Haves

Hands-on experience with calibration, instrumentation, preventive maintenance, equipment troubleshooting, or repair.
Familiarity with biomedical equipment calibration, preventive maintenance, troubleshooting, or repair.
Experience supporting or executing verification and validation (V&V) activities, process validations, or equipment qualifications (IQ/OQ/PQ).
Associate’s or Bachelor’s degree in Science, Technology, Engineering, Mathematics, or related field; or equivalent military training in calibration, metrology, instrumentation, or electronics.
Relevant experience working in highly regulated environments (e.g., GMP, GCP, GLP, ISO 13485, medical device, biotech, or pharmaceutical settings).
Familiarity with root-cause analysis techniques, deviation management, change control, or continuous improvement of quality processes.
Experience generating or executing test protocols, recording data, and contributing to calibration, qualification, or V&V reports and technical documentation.

Responsibilities

Calibrate, perform preventive maintenance, troubleshoot, and repair instruments, devices, and equipment in the quality program (including biomedical devices, industrial instrumentation, lasers, RF systems, and related technologies) with little to no supervision, ensuring accuracy, reliability, and compliance.
Assist in the check-out, start-up, installation, acceptance, and commissioning of new or modified equipment; support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities; determine and requisition parts required for maintenance and repairs.
Execute and document verification and validation activities for engineering work, processes, and equipment, including following or supporting protocols, collecting data, recording results, investigating deviations, and maintaining traceability.
Adhere to cGxP guidelines, SOPs, safety rules/regulations, and quality system requirements; apply good documentation practices and clearly explain technical issues, calibration processes, and V&V/qualification results to cross-functional peers and stakeholders.
Collaborate with engineering, quality, manufacturing, and other teams to resolve equipment and quality issues, support root-cause analysis, and drive timely closure; contribute to continuous improvement of equipment quality processes, procedures, templates, and workflows.
Support change control and related quality activities for equipment and processes by providing accurate data, documentation, and technician-level input; maintain accurate equipment records and calibration status.