Cleanroom Metrology Technician - ISO 13485
Assist Staffing
Job Description
Job Description
Join Our Precision-First Team
Direct-hire opportunity in a medical device cleanroom where your measurement expertise keeps products safe and compliant. If you thrive on accuracy and disciplined process control, this role is for you.
Why This Role- Work at the intersection of quality and patient impact
- Hands-on metrology with plastics and injection-molded parts
- ISO 13485, GMP, and FDA-aligned environment
- Conduct precise in-process and final inspections
- Measure components and assemblies using calipers, micrometers, gauges, and CMM
- Translate blueprints/specs into acceptance criteria and inspection plans
- Detect defects, escalate issues, and verify corrective actions as needed
- Complete, accurate documentation of inspection outcomes
- Partner with production to validate material and product quality
- Maintain cleanroom discipline and follow ISO/GMP/SOPs
- 1–2 years in a manufacturing quality inspection role
- Strong background with plastic or injection-molded components (preferred)
- Proficiency with blueprint reading and precision measurement tools
- Ability to work a 12-hour, 2-2-3 rotating schedule (including weekends)
- Comfort standing for long periods; able to lift up to 30 lbs with or without accommodation
- Detail orientation and solid communication skills
- Medical device or other regulated manufacturing experience
- Experience with CMM and advanced inspection equipment
- Working knowledge of SPC and quality systems
- 2-2-3 rotation on 12-hour shifts
- Day: 6:00am – 6:00pm
- Night: 6:00pm – 6:00am (10% differential)
- Quality Inspection Experience; Continuous Improvement
- ISO 13485; FDA Regulations; GMP
- Statistical Process Control (SPC)
- Pharmaceutical and SOP-driven environments
- Tolerance analysis; Precision measurement & hand metrology
- Blueprint reading
- Coordinate Measuring Machine (CMM)
- Measurement gauges
- Calipers and micrometers
Vacancy posted 10 days ago
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