Quality Engineer 1 - Sterilization Validation

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

Benefits offered by this job

Medtronic Incentive Plan (MIP)

Job summary

Medtronic Ireland is seeking a Sterilisation Validation/Microbiology professional to support quality and regulatory activities within the Sterilisation Validation Department. The role emphasizes GMP compliance, documentation, and collaboration across manufacturing and design teams.

The ideal candidate will have 1–2 years of Sterilisation Validation/Microbiology experience, a relevant technical degree, and strong communication skills.

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

• Support routine Sterility Assurance activities e.g GMP, Standards Compliance, Cleanroom Risk Assessment and related reviews.
• Support Sterility Assurance activities for new products and change control, developing strong partnering relationships with manufacturing and design teams.
• Participate in root cause investigations and continuous improvement in day-to-day activity.
• Support cross functional teams in design protocols to ensure products are evaluated/tested for regulatory standards.
• Deliver on projects and coordinate with stakeholders to meet defined timeframes.
• Support projects in audits and submission preparation, addressing questions about submissions.
• Perform calculations, technical and record-keeping duties in line with policies and standards.
• Review systems and processes for optimisation and troubleshooting.
• Adhere to site wide procedures and practices for Safety & GMP.

Skills

Sterilisation Validation

Microbiology

GMP

Documentation

Communication skills

Team player

Cross-functional collaboration

Education

Bachelor's degree in Science/Engineering

Job description

About Medtronic

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.

Benefits & Compensation

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).

Equal Employment Opportunity

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

E-Verify

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.

Company Culture

Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world.

Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation.

You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care