Quality Engineer 1 - Sterilization Validation

Medtronic; Galway; Vor Ort; EUR 42.000 - 62.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Sterilisation Validation

Microbiology

GMP knowledge

Communication skills

Team player

Cross-functional collaboration

Ausbildung

Bachelor's degree in Science or Engineering

Jobbeschreibung

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

At our Sterilisation Validation Department in Medtronic, plc, we focus on product quality excellence and providing exemplary service to the businesses & operating units we support. Our Sterilisation Quality Engineers anticipate and respond to changing sterility requirements, provide strategic leadership to influence the global sterility environment to benefit the patients we serve and are directly involved in building the organisation in support of Sterility Assurance assessments for New Product Development and site transfers.

Support routine Sterility Assurance activities e.g GMP, Standards Compliance, Cleanroom Risk Assessment, Limits review, Dose Audit activity, Cycle Requalification, Supplier Change control etc.

Support Sterility Assurance activities for new products and change control, developing strong partnering relationships with these groups, at both manufacturing and design sites.

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.

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.

Perform calculations, technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements.

Review systems and processes for optimisation and troubleshooting. - Adhere to all relevant site wide procedures and practices for Safety & GMP.

Key Skills & Experience

• 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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 41,600.00 EUR - 62,400.00 EUR | The final salary within this range will be determined based on objective, job-related criteria, including relevant experience, skills and qualifications, in accordance with our compensation framework.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).