Quality Technician

Position Summary

The Quality Technician is responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. The Quality Technician supports production and quality operations by assisting in performing and documenting problem solving investigations, conducting pre-reviews of Customer product and run set-up and final acceptance/run release through review of run records/device history records. 

Quality Technicians assist in identifying, documenting and investigating non-conformances, Customer complaints, CAPAs and internal/external audit findings. They work with operations and quality team members to perform and document problem-solving investigations and continuous improvement initiatives. In addition, to performing run releases, Quality Technicians may execute review of calibration and operating logs.

What You'll Do as a Quality Technician

• Conducts pre-review on incoming product to confirm compliance to the Customer’s processing specifications, verifies calculations, correct dose range, approved product codes, dosimeter placements and special instructions.
• Releases processing runs after product has been processed, ensuring all processing parameters and Customer specifications have been met and the run file (device history record) is accurate and complete.
• In Lab facilities, review and release laboratory reports, ensuring tests comply with requirements and Customer requests.
• Assists in Quality investigations, associated problem-solving activities and continuous improvement initiatives.
• Identifies, documents and investigates non-conformances to establish sustainable corrective actions. Supports investigations into Customer complaints and internal/external audit observations.
• Assist in the development (and revisions to) quality system policies and procedures.
• Executes review of operating logs (i.e. spectrophotometer, pre-conditioning, aeration), preventive maintenance schedules, maintenance work orders, and site calibration activitiesto ensure timely and accurate recordkeeping. Responsible to escalate matters of noncompliance to site Quality Lead/Manager.
• Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations.
• Complete other duties as assigned.

The Experience, Skills, and Abilities Needed

• Minimum of one (1) year of experience in a manufacturing or processing environment or other technical/scientific field with an Associates Degree (Engineering/Scientific) OR 4 Years of experience with a high school degree or GED.

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