Medical Device Quality Inspector & Analyst

Nuclein, LLC.; Austin (TX); Sur place; USD 42 000 - 54 000; Plein temps

Résumé du poste

Nuclein, LLC. is seeking a Quality Control Technician to inspect and test diagnostic medical devices, subassemblies, and components. You will maintain GMP standards, read technical drawings, and analyze data to ensure compliance with specifications.

The role emphasizes documentation, deviation reporting, and ongoing support for test method development and continuous improvement in a regulated environment.

Qualifications

• H.S. diploma or equivalent required; Associate’s degree or higher in a technical discipline preferred.
• Minimum 1 year experience required; 2+ years in medical device or other regulated industry preferred.
• Quality certification such as ASQ CQI, CQT or ASME GD&T preferred.
• Strong computer skills and experience with laboratory equipment.
• Strong attention to detail and problem solving skills.
• Familiarity with measurement tools, data processing, quality control principles and processes.

Responsabilités

• Perform sampling and inspections in a laboratory environment.
• Inspections can include visual, dimensional, optical, and functional/analytical tests.
• Maintain work area and equipment to GMP standards, perform equipment maintenance and metrology.
• Perform data analysis, record results, and archive quality records.
• Read and interpret technical drawings, schematics, specifications, etc.
• Recognize and report deviations, non-conformances, and out of specification events promptly and accurately, perform material quarantine.
• Review quality records for completeness, accuracy, and compliance.
• May author work instructions and support test method development and continuous improvement.
• May participate in validation activities.
• May support quality audits.

Connaissances

Attention to detail

Problem solving

Reading technical drawings

Data analysis

GMP knowledge

Laboratory skills

Formation

High school diploma

Associate degree or higher in a technical discipline

Outils

Metrology equipment

Laboratory instruments

Description du poste

Nuclein, LLC. is seeking a Quality Control Technician to inspect and test diagnostic medical devices, subassemblies, and components. You will maintain GMP standards, read technical drawings, and analyze data to ensure compliance with specifications.

The role emphasizes documentation, deviation reporting, and ongoing support for test method development and continuous improvement in a regulated environment.