Quality Assurance Shift Engineer

Bausch + Lomb; Dublin; On-site; EUR 60,000 - 85,000; Full time

Job summary

Bausch + Lomb is seeking a Quality Assurance Shift Engineer to support the Manufacturing QA Manager in ensuring that manufactured products meet specifications in a GMP-compliant environment. This shift role requires hands-on oversight of non-conformances, CAPA, validation documentation, PFMEAs and continuous improvement, with close collaboration across operations, engineering and QA.

You will ensure compliance with FDA, ISO, MDR requirements, manage lot disposition on shift, and provide

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.
• Microsoft Office experience.

Responsibilities

• Determine appropriate 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, preparation and update of applicable PFMEAs, CAPA activity and continuous improvement.
• Act as the Manufacturing Quality Management interface with operations and engineering.
• Disposition product as appropriate and manage non-conformance activity.
• Highlight relevant issues and participate in or lead resolution.
• Review validation documentation and change requests.
• Participate in Quality System continuous improvement activities.
• Ensure compliance with applicable GMP and medical-device regulatory requirements, including FDA, ISO, MDD & MDR requirements, and internal documentation.
• Provide direction to ensure product quality is maintained at all stages of manufacturing.
• Provide shift direction on QASL issues.
• Complete non-conformance rationales as required.
• Complete additional requirements specified by the Manufacturing Quality Manager.
• Follow Standard Operating Procedures at all times.
• Maintain awareness of applicable standards and QMS requirements.
• Follow gowning procedures and entry rules for manufacturing and controlled areas.
• Follow Personal Hygiene Rules defined in the GMP Training Programme and notify supervision of health conditions that may affect product quality.
• Maintain a clean and tidy work area.

Skills

Analytical skills

Process-control systems

Six Sigma & Lean tools

Self-motivated & prioritization

Decisive, effective communicator

Microsoft Office experience

Education

Bachelor's degree in Engineering or Science

Job description

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Scope of Position

The Quality Assurance Shift Engineer supports the Manufacturing QA Manager in ensuring that manufacturing produces product that meets specification in an environment compliant with all relevant standards.

This is a shift position.

Key Activities / Responsibilities

• Determine appropriate 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, preparation and update of applicable PFMEAs, CAPA activity and continuous improvement.

• Act as the Manufacturing Quality Management interface with operations and engineering.

• Disposition product as appropriate and manage non-conformance activity.

• Highlight relevant issues and participate in or lead resolution.

• Review validation documentation and change requests.

• Participate in Quality System continuous improvement activities.

• Ensure compliance with applicable GMP and medical-device regulatory requirements, including FDA, ISO, MDD & MDR requirements, and internal documentation.

• Provide direction to ensure product quality is maintained at all stages of manufacturing.

• Provide shift direction on QASL issues.

• Complete non-conformance rationales as required.

• Complete additional requirements specified by the Manufacturing Quality Manager.

• Follow Standard Operating Procedures at all times.

• Maintain awareness of applicable standards and QMS requirements.

• Follow gowning procedures and entry rules for manufacturing and controlled areas.

• Follow Personal Hygiene Rules defined in the GMP Training Programme and notify supervision of health conditions that may affect product quality.

• Maintain a clean and tidy work area.

Key Relationships

• Production colleagues

• Production managers

• Maintenance technicians

• Warehouse colleagues

• Process Excellence Department

• Training Department

• QA Department

• Engineering Department

• HR Department

• R&D Department

Qualifications / Training

• 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.

• Microsoft Office experience.

Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.