Senior Quality Engineer – Medical Devices Validation Lead

Jabil; Le Locle; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

Bonus system

Extra vacation days

Benefits

Zusammenfassung

Jabil Le Locle, Switzerland is seeking a Senior Quality Engineer (m/f/d) for a 15-month temporary role. You will join the quality team and collaborate with production and engineering to ensure products meet quality and regulatory requirements.

The role emphasizes validation, CAPA/Kaizen, supplier quality interfaces, and risk assessment of manufacturing processes, with English and French fluency required.

Qualifikationen

• Bachelor’s degree preferred or equivalent experience.
• At least 5 years of experience in manufacturing, quality or engineering.
• Experience in ISO 13485 and 21CFR820 medical device regulated industry.
• Fluent in English and French.

Aufgaben

• Collaborate with production and engineering to ensure products meet quality and regulatory requirements.
• Serve as validation SME for new equipment, products, processes, and tests.
• Interface with suppliers to review validation activities and assess First Article Inspection (FAI).
• Create quality control documents and recommend QC tools and methods.
• Prepare First Article Inspection instructions and inspection plans.
• Assess nonconforming products and support disposition and resolutions.
• Participate in nonconformities and CAPA investigations and improvements.
• Lead product and process improvement quality efforts through CAPA and Kaizen.
• Support audits with Gemba walks and remediation actions.
• Support risk assessment of manufacturing processes.

Kenntnisse

Analytical skills

Problem-solving

Data interpretation

Cross-functional collaboration

Attention to detail

Ausbildung

Bachelor’s degree or equivalent

Tools

MES

SAP

ETQ

Babtec

Jobbeschreibung

Jabil Le Locle, Switzerland is seeking a Senior Quality Engineer (m/f/d) for a 15-month temporary role. You will join the quality team and collaborate with production and engineering to ensure products meet quality and regulatory requirements.

The role emphasizes validation, CAPA/Kaizen, supplier quality interfaces, and risk assessment of manufacturing processes, with English and French fluency required.