Quality Engineer II - MedTech & Medical Devices

Biopharma Careers; Santa Clara (CA); Vor Ort; USD 105.000 - 115.000; Vollzeit

Zusammenfassung

Johnson & Johnson is seeking a Quality Engineer II for our Santa Clara site. You will develop and maintain quality standards for processing materials into finished products, and design procedures for inspection, testing, and evaluation.

You will support manufacturing and collaborate cross-functionally to resolve technical problems. The role requires a BS in Bioengineering or related field with 2 years in quality engineering, experience in the medical device industry, and strong technical writing

Qualifikationen

• Bachelor’s degree in Bioengineering, Biomedical Engineering or related field with 2 years in quality engineering.
• Experience in medical device industry and non-conformance investigations.
• Experience with IQ, OQ, PQ and process validation activities.
• Technical writing for investigations, protocols and reports.
• Knowledge of risk management including FMEA.
• Statistical analysis using Minitab and DOE.

Aufgaben

• Develop and maintain quality standards for materials and processes.
• Design procedures for inspection, testing, and evaluation.
• Support manufacturing and cross-functional teams to resolve issues.
• Investigate customer complaints and non-conformances.
• Prepare validation protocols and reports.
• Participate in risk management and DV&V testing.

Kenntnisse

Statistical analysis

Technical writing

Process validation

DOE

FMEA

Quality systems

Ausbildung

Bachelor’s degree in Bioengineering/Biomedical Engineering or related field

Tools

Minitab

Jobbeschreibung

Johnson & Johnson is seeking a Quality Engineer II for our Santa Clara site. You will develop and maintain quality standards for processing materials into finished products, and design procedures for inspection, testing, and evaluation.

You will support manufacturing and collaborate cross-functionally to resolve technical problems. The role requires a BS in Bioengineering or related field with 2 years in quality engineering, experience in the medical device industry, and strong technical writing