Quality Technician

We are seeking a detail-oriented Quality/Calibration Technician to support our manufacturing operations. This role is responsible for testing, inspection, calibration, and quality assurance processes to ensure all products meet engineering specifications and regulatory standards. This position plays a critical role in maintaining product quality within a medical device manufacturing environment, supporting continuous improvement efforts and compliance with ISO and FDA requirements.

Key Responsibilities:

Product Testing & Inspection Conduct routine testing and validation activities to verify product functionality and compliance with specifications Conduct R&R's and gage studies to ensure that the gaging methods work properly for the intended uses Calibration & Equipment Management Maintain and monitor calibration schedules for measurement tools and equipment Investigate and resolve gaging discrepancies in collaboration with engineering and production teams Maintain calibration records (in-house and outsourced) Purchase and manage gages, including NIST traceable certification documentation Perform investigations on failed calibrations and implement corrective actions Quality & Continuous Improvement Assist in root cause analysis and corrective/preventive actions (CAPA) Collaborate with cross-functional teams to resolve quality issues and improve processes Support internal and external audits, ensuring compliance with ISO 13485 and FDA regulations Assist in training operators on inspection methods and quality standards Communication & Coordination Communicate with suppliers to ensure proper gage inventory levels Work with customers and vendors on custom gage requirements based on specifications Qualifications High school diploma or equivalent required; technical or quality certifications preferred 2+ years of experience in quality control/assurance (medical device or regulated industry preferred) Experience with precision measurement tools (calipers, micrometers, gauges) Ability to read and interpret engineering drawings, blueprints, and GD&T Familiarity with

ISO 13485, FDA

regulations, and Quality Management Systems (QMS) Strong organizational, problem-solving, and time management skills Proficient in

Microsoft Office Preferred Qualifications:

Experience with GAGEtrak CMM programming (PC-DMIS or CMM Manager) Keyence vision system programming Knowledge of

ASME Y14.43 CAD

software experience 1st shift (8am -4pm)