QC Inspector – Cardiac Medical Devices

BIOTRONIK; Minneapolis (MN); Sur place; USD 72 000 - 96 000; Plein temps

Avantages offerts par ce poste

Bonus program

Health insurance

Retirement plans

Paid time off

Résumé du poste

BIOTRONIK EP CRC in Tustin, CA is seeking a QC Inspector to ensure first article, in-process and final inspections across catheter manufacturing. You will write inspection protocols, review drawings, and support quality engineering to maintain regulatory compliance.

The role requires strong attention to detail, GMP/ISO13485 familiarity, and 5+ years of QC inspection experience in Class III catheter manufacturing. Competitive salary, bonus program and comprehensive benefits are offered.

Qualifications

• High school diploma; bachelor’s degree preferred.
• Experience with QC inspection and measurement techniques.
• Experience with measuring devices such as meters, gauges, calipers, multimeter and other measuring instruments.
• Knowledge of GMP.
• ISO 13485 experience preferred.
• At least 5 years of QC inspector experience in class III catheter manufacturing.

Responsabilités

• Perform FAI of parts per CRC EP procedures and conduct various inspections of incoming materials.
• Support receiving process and verify label accuracy.
• Coordinate with procurement/engineering for documentation.
• Perform visual, mechanical, electrical, and dimensional inspections of materials and assemblies.
• Conduct electrical and mechanical tests (continuity, Hi-Pot, Peel, Tensile).
• Approve finished products per specifications and enable re-work when needed.
• Record inspections and review DHRs for GDP compliance.
• Compile and analyze inspection data using Excel and other systems.

Connaissances

Attention to detail

Team player

Communication skills

Basic math skills

Documentation skills

Reporting skills

Analytical skills

Formation

High school diploma

Bachelor’s degree preferred

Outils

Meters

Gauges

Calipers

Multimeter

Measuring instruments

Description du poste

BIOTRONIK EP CRC in Tustin, CA is seeking a QC Inspector to ensure first article, in-process and final inspections across catheter manufacturing. You will write inspection protocols, review drawings, and support quality engineering to maintain regulatory compliance.

The role requires strong attention to detail, GMP/ISO13485 familiarity, and 5+ years of QC inspection experience in Class III catheter manufacturing. Competitive salary, bonus program and comprehensive benefits are offered.