Quality Engineer II – Validation and Compliance

About the role

Jabil is seeking a Quality Engineer II to lead validation strategies and quality initiatives for new product introductions, technology implementations, process improvements, and manufacturing changes. The role ensures compliance with regulatory standards and supports operational excellence at the Bettlach site.

Key responsibilities

• Lead validation strategies for new product introductions, technology roll‑outs, and process improvements.
• Plan, execute, and review Process Validation (IQ, OQ, PQ), Computer System Validation (CSV) and equipment qualification activities.
• Develop, execute, and review Test Method Validations (TMV) to guarantee accurate and reliable testing methods.
• Maintain compliance with GxP, GAMP, ISO 13485 and internal quality standards, providing documentation for audits and inspections.
• Provide technical expertise on manufacturing equipment, support equipment lifecycle management, design transfer, and new product launches.

Required profile

• 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.
• Background in medical device, pharmaceutical or other regulated industries.
• Familiarity with new product introduction (NPI), design transfer and equipment lifecycle management is a plus.

Required skills

• GxP compliance
• GAMP methodology
• ISO 13485 standards
• Process Validation (IQ, OQ, PQ)
• Computer System Validation (CSV)
• Test Method Validation (TMV)

What we offer

• Progressive employment conditions with a long‑term perspective
• A responsible and varied role in a global company with strong local presence
• High level of personal responsibility and independent work
• Creative and learning‑focused workplace environment
• Bonus system, extra vacation days and additional benefits