Quality Technician — ISO/FDA Compliance & QC Testing

Regulatory Jobs

Florida

On-site

USD 24,000 - 35,000

Full time

5 days ago

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Job summary

STERIS is hiring a Quality Technician to support ISO 9001/13485, FDA, EU MDR compliance and to assist in calibration, environmental monitoring and product release activities. The role involves problem solving, data entry and validation of batch records in a manufacturing setting.

The position supports manufacturing operations, reviews DHRs and may participate in problem-solving investigations with the operations team.

Qualifications

Minimum of three (3) years of experience in a manufacturing or repair environment or other technical production tasks with a high school diploma or equivalent.
Minimum of one (1) year of experience in a manufacturing or repair environment or other technical production tasks with an Associate Degree.
Experience with mathematical skills including ratios, proportions and basic algebra.

Responsibilities

Assists in production line Quality investigations and associated problem-solving activities.
May coordinate and conduct in-process and final QC product acceptance testing, depending on facility.
Investigates production line stoppages to identify corrective actions.
Identifies and documents product and process non-conformances.
Participates on a Material Review Board to review and process non conformance reports.
Reviews DHRs and supports batch record release.
Enters and retrieves Quality data from local and global systems.
Performs site calibration activities and recordkeeping.
Executes environmental monitoring processes and recordkeeping.