QA Shift Engineer — Medical Devices & GMP

Bausch & Lomb GmbH; Waterford; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

Bausch & Lomb in Waterford, Ireland, is seeking a Quality Assurance Shift Engineer to support the Manufacturing QA Manager in delivering product that meets specifications in a GMP environment.

The role is shift-based and requires hands-on QA oversight of manufacturing, non-conformances, validation docs, CAPA and continuous improvement, while ensuring compliance with FDA, ISO, MDD/MDR and internal procedures.

Qualifications

• Minimum three years' experience in a regulated pharmaceutical or medical-device environment.
• Full understanding of regulatory-standard requirements.
• Third-level qualification, ideally in Engineering or Science.
• Strong analytical skills and good knowledge of process-control systems.
• Knowledge of Six Sigma and Lean tools.
• Self-motivated and able to manage multiple priorities.
• Decisive, effective communicator, self-motivated, achievement-focused and a strong team member.

Responsibilities

• Determine lot-disposition decisions on a shift-by-shift basis.
• Manage, review and approve non-conformances.
• Provide quality oversight for manufacturing, including approval of validation documentation, PFMEAs, CAPA activity and continuous improvement.
• Act as the Manufacturing Quality Management interface with operations and engineering.
• Disposition product and manage non-conformance activity.
• Highlight issues and participate in or lead resolution.
• Review validation documentation and change requests.
• Participate in Quality System continuous improvement activities.
• Ensure compliance with GMP and medical-device regulatory requirements (FDA, ISO, MDD & MDR) and internal docs.
• Provide direction to ensure product quality at all stages of manufacturing.

Skills

Analytical skills

Communication

Self-motivated

Team player

Education

Engineering or Science degree

Tools

Six Sigma

Lean

Job description

Bausch & Lomb in Waterford, Ireland, is seeking a Quality Assurance Shift Engineer to support the Manufacturing QA Manager in delivering product that meets specifications in a GMP environment.

The role is shift-based and requires hands-on QA oversight of manufacturing, non-conformances, validation docs, CAPA and continuous improvement, while ensuring compliance with FDA, ISO, MDD/MDR and internal procedures.