Sterility Quality Engineer I — Drive GMP Excellence

Medtronic; Galway; On-site; EUR 42,000 - 62,000; Full time

Job summary

Medtronic is seeking a Sterilisation Quality Engineer to join our Sterilisation Validation Department in Ireland. The role focuses on sterile product quality, GMP compliance, and collaboration with manufacturing and design teams to ensure regulatory standards are met.

You will support routine sterility activities, participate in investigations, and help drive continuous improvement across projects, audits, and change controls. A minimum Level 7 degree in a relevant technical field is required.

Qualifications

• Minimum Level 7 degree in a relevant technical discipline e.g. Science or Engineering.
• 1-2 years' experience with Sterilisation Validation/Microbiology is desirable.
• Excellent understanding of GMP and documentation required.
• Dynamic team player with good communication skills.
• Can work effectively and proactively as an individual or on cross functional teams.

Responsibilities

• Deliver on projects assigned and works with other stakeholders to achieve desired results within defined timeframes.
• Support your projects in internal and external audits and in submission preparation, addressing any questions regarding these submissions.
• Participate in root cause investigations and continuous improvement in day-to-day activity, initiating appropriate corrective actions and following through to implementation.
• Support cross functional teams in design protocols to ensure that new products/product changes are adequately evaluated/tested to guarantee compliance to all regulatory standards.
• Review systems and processes for optimisation and troubleshooting. - Adhere to all relevant site wide procedures and practices for Safety & GMP.

Skills

Sterilisation Validation

Microbiology

GMP knowledge

Communication skills

Team player

Cross-functional collaboration

Education

Bachelor's degree in Science or Engineering

Job description

Medtronic is seeking a Sterilisation Quality Engineer to join our Sterilisation Validation Department in Ireland. The role focuses on sterile product quality, GMP compliance, and collaboration with manufacturing and design teams to ensure regulatory standards are met.

You will support routine sterility activities, participate in investigations, and help drive continuous improvement across projects, audits, and change controls. A minimum Level 7 degree in a relevant technical field is required.