Quality Engineer II

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.

Key responsibilities

• Lead validation strategies for new product introductions, technology implementations, and process improvements.
• Plan, execute, and review Process Validation (IQ, OQ, PQ), Computer System Validation (CSV), and equipment qualification.
• Develop, execute, and review Test Method Validations (TMV) to ensure 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, supporting equipment lifecycle management 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.

Required skills

• GxP
• GAMP
• ISO 13485
• Process Validation (IQ, OQ, PQ)
• Computer System Validation (CSV)
• Test Method Validation (TMV)
• Manufacturing equipment expertise

What we offer

• Progressive employment conditions with a long‑term perspective.
• High level of personal responsibility and independent work in a global company.
• Bonus system, extra vacation days and other benefits.