Quality Engineer - Cardiac Medical Devices

Kelly; Irvine (CA); Sur place; USD 41 000 - 55 000; Plein temps

Avantages offerts par ce poste

Medical

Dental

Vision

401K

Vacation

Sick Time

Holiday Pay

Résumé du poste

Kelly Services (on behalf of Johnson & Johnson) in Irvine, CA is hiring a qualified R&D/Quality Engineer to support development, transfer, and lifecycle management of EP catheters and medical devices. This long term contract role focuses on quality assurance, process validation, risk management, and data-driven improvements.

The candidate will collaborate with R&D, Operations, and external facilities, ensuring compliance with design controls and MDR/GSPR requirements.

Qualifications

• Experience in quality engineering for medical devices.
• Familiarity with quality tools and process validation.
• Ability to analyze data with Six Sigma/DOE methods.

Responsabilités

• Support development and lifecycle management of products.
• Lead quality assurance activities across projects.
• Perform risk analyses (AFMEA, DFMEA, PFMEA) and CAPA actions.
• Develop and implement QC plans and validation protocols.
• Utilize statistics (DOE, SPC) to improve processes.

Connaissances

Quality tools

Six Sigma

SPC

DOE

Design of Experiments

Outils

Process validation

Equipment qualification

Description du poste

Kelly Services (on behalf of Johnson & Johnson) in Irvine, CA is hiring a qualified R&D/Quality Engineer to support development, transfer, and lifecycle management of EP catheters and medical devices. This long term contract role focuses on quality assurance, process validation, risk management, and data-driven improvements.

The candidate will collaborate with R&D, Operations, and external facilities, ensuring compliance with design controls and MDR/GSPR requirements.