The Quality Metrology Technician is responsible for supporting quality assurance and metrology functions to ensure that products meet internal and customer specifications. This role involves analyzing processes, identifying root causes of defects, recommending improvements, and supporting validation and inspection activities. The technician works closely with engineering, production, and quality teams to drive continuous improvement and maintain compliance with regulatory standards.
Key Accountabilities:
- ISO 13485 requirements
- FDA CFR 820 regulations
- Micron Quality System requirements
- Auditing and Statistical Process Control (SPC)
Education & Experience
- Bachelor’s degree in engineering or related field, or a minimum of 5 years in a Metrologist role
- Medical device manufacturing experience preferred
- ASQ Certified Calibration Technician
- Strong understanding of metrology and statistical analysis.
- Working knowledge of plastics injection molding and metal manufacturing
- Proficient in CMM operation and programming (minimum 3-5 years with Hexagon PC-DMIS).
- Skilled in using optical and mechanical measurement tools.
- Experience with ERP systems (IQMS preferred).
- Familiarity with ISO 13485 and FDA CFR 820 regulations.
- Proficient in Microsoft Office Suite and Mini Tab
- Strong organizational, communication, and facilitation skills.
- Ability to work independently in a fast-paced, dynamic manufacturing environment.
- Experience with validation protocols
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