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Job Description
Job Overview We are seeking a detail-oriented and proactive Quality Technician to join our dynamic manufacturing team. In this role, you will be instrumental in ensuring our products meet the highest standards of quality, safety, and compliance. Your expertise will help maintain rigorous quality systems, support continuous improvement initiatives, and uphold regulatory requirements such as
ISO 13485, FDA
regulations, and
ISO 9001.
This position offers an exciting opportunity to work with precision measuring instruments and advanced inspection systems to deliver excellence at every stage of production. Duties Perform comprehensive quality inspections using precision measuring instruments such as calipers, micrometers, and vision inspection systems to verify product dimensions and specifications. Conduct regular quality audits across manufacturing processes to ensure adherence to
ISO 13485, ISO 9001, CGMP
(Current Good Manufacturing Practice), and HACCP standards. Utilize Calypso software and other data collection tools to analyze quality data, identify trends, and implement corrective actions. Operate coordinate measuring machines (CMM) for detailed dimensional analysis of complex components. Support quality assurance activities by reviewing manufacturing documentation, conducting root cause analysis, and participating in CAPA (Corrective and Preventive Action) initiatives. Assist in maintaining compliance with FDA regulations by ensuring all products meet safety and efficacy standards through rigorous inspection protocols. Lead or participate in internal and external quality audits to verify system effectiveness and identify areas for improvement. Collaborate with cross-functional teams to improve quality management systems, streamline inspection procedures, and enhance overall product quality. Skills Strong knowledge of quality systems including
ISO 13485, ISO
9001, CGMP, HACCP, and FDA regulations. Proficiency with calibration and use of precision measuring instruments such as calipers, micrometers, and vision inspection systems. Experience operating coordinate measuring machines (CMM) for detailed dimensional analysis. Familiarity with Calypso software for data collection and analysis related to quality metrics. Excellent analysis skills to interpret inspection data, identify root causes of issues, and recommend solutions. Ability to perform thorough quality audits and support continuous improvement efforts within manufacturing environments. Strong understanding of quality control processes including visual inspections, measurement techniques, and documentation practices. Effective communication skills for documenting findings clearly and collaborating with teams on corrective actions. Join us as a Quality Technician if you're passionate about precision craftsmanship, dedicated to maintaining the highest standards of quality assurance, and eager to contribute to a culture of continuous improvement!