Quality Engineer II: Validation & NPI for Med Devices

Jabil Malaysia; Bettlach; Vor Ort; CHF 85.000 - 110.000; Vollzeit

Benefits dieser Stelle

Bonus system

Extra vacation days

Many other benefits

Zusammenfassung

Jabil Switzerland is seeking a Quality Engineer II (m/f/d) for Bettlach, Switzerland, 100% location, limited until end 2027. You lead validation strategies for new products, technology implementations, and process improvements to ensure regulatory compliance and product quality.

Responsibilities include IQ/OQ/PQ, CSV, TMV, and documentation. Strong knowledge of GxP, GAMP, ISO 13485 and validation best practices is required; experience in regulated industries is a plus.

Qualifikationen

• Strong knowledge of GxP, GAMP, ISO 13485 and validation best practices.
• Experience with Process Validation (IQ/OQ/PQ) and CSV activities.
• Technical understanding of manufacturing processes and equipment.
• Experience in medical device, pharmaceutical, or other regulated industries.
• Knowledge of new product introduction (NPI), design transfer, and equipment lifecycle management is highly desirable.

Aufgaben

• Lead validation strategies and quality initiatives for new product introductions, technology implementations, process improvements, and manufacturing changes to ensure compliance and product quality.
• Plan, execute, and review validation activities, including IQ/OQ/PQ, CSV, and equipment qualification to support operational excellence and regulatory requirements.
• Develop, execute, and review Test Method Validations (TMV) to ensure testing methods are accurate, reliable, and fit for purpose.
• Ensure compliance with GxP, GAMP, ISO 13485, and internal quality standards, while maintaining thorough documentation and supporting audits and inspections.
• Provide technical expertise on manufacturing equipment and processes, supporting equipment lifecycle management, design transfer activities, and successful new product launches.

Kenntnisse

GxP knowledge

GAMP knowledge

ISO 13485 knowledge

Validation expertise

Process Validation

CSV experience

Manufacturing equipment know-how

Jobbeschreibung

Jabil Switzerland is seeking a Quality Engineer II (m/f/d) for Bettlach, Switzerland, 100% location, limited until end 2027. You lead validation strategies for new products, technology implementations, and process improvements to ensure regulatory compliance and product quality.

Responsibilities include IQ/OQ/PQ, CSV, TMV, and documentation. Strong knowledge of GxP, GAMP, ISO 13485 and validation best practices is required; experience in regulated industries is a plus.