Quality Control Inspector for Medical Catheters

Biotronik; Tustin (CA); On-site; USD 72,000 - 96,000; Full time

Benefits offered by this job

Health insurance

Bonus program

Paid time off

Retirement plans

Job summary

BIOTRONIK EP CRC in California is seeking a Quality Control Inspector to ensure strict adherence to CRC EP quality systems. This role collaborates with Manufacturing and Engineering to perform FAI inspections, in-process and final testing, and document control across GDP processes.

Superior attention to specification details and problem-solving skills are required. The position focuses on supporting regulatory readiness for cardiac catheter manufacturing with a strong emphasis on data analysis,

Qualifications

• High school diploma required; bachelor’s degree preferred.
• Experience with quality control inspection and measurement techniques.
• Knowledgeable of GMP and ISO 13485 preferred.
• At least 5 years of QC inspector experience in class III catheter manufacturing.

Responsibilities

• Perform First Article Inspection (FAI) of parts and conduct visual, mechanical, electrical, and dimensional inspections.
• Support the receiving process and verify labels against artwork and specs.
• Collect incoming material documents with procurement/engineering as needed.
• Inspect in-process and final assemblies and verify tolerances and specifications.
• Perform electrical testing (Hi-Pot, insulation) and mechanical testing (Tensile, Peel).
• Approve finished products and coordinate rework as required.
• Record inspections and maintain DHRs in compliance with GDP practices.
• Compile quality data in Excel and support investigations and CAPA.

Skills

Quality control

Inspection techniques

Measuring devices

GMP knowledge

ISO 13485 knowledge

Communication skills

Education

High school diploma

Bachelor's degree preferred

Tools

Microsoft Excel

Measuring instruments

Job description

BIOTRONIK EP CRC in California is seeking a Quality Control Inspector to ensure strict adherence to CRC EP quality systems. This role collaborates with Manufacturing and Engineering to perform FAI inspections, in-process and final testing, and document control across GDP processes.

Superior attention to specification details and problem-solving skills are required. The position focuses on supporting regulatory readiness for cardiac catheter manufacturing with a strong emphasis on data analysis,