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Qa engineer - sterilisation

Freudenberg Medical
Qa engineer
Posted: 24 April
Offer description

Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.
Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities including precision molding and extrusions, complex catheters, hypotubes, and coatings.
Benefits

Flexible Work Models: We allow for flexible work models to ensure both professional and personal success.
Health Insurance: Rely on comprehensive services whenever you need it.
Company Pension: Save for retirement with the company's help.
Personal Development: We offer a variety of trainings to ensure you can develop in your career.
Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.

Carrick-on-Shannon, Co. Leitrim
Hybrid Work
Freudenberg Medical Ireland Ltd.
QA Engineer - Sterilisation
Responsibilities

Take ownership as the go-to expert for sterilisation, supporting projects from concept through to commercialisation.
Play a key role in bringing new products to life, advising on the most effective sterilisation strategies during NPI.
Lead and shape sterilisation validation activities, ensuring processes are robust, compliant, and audit-ready.
Partner closely with engineering, R&D, operations, and global teams to drive quality and innovation.
Evaluate the impact of product, process, or supplier changes, ensuring patient safety and product integrity are always protected.
Influence and support regulatory submissions, helping to bring products to market efficiently.
Drive continuous improvement across sterilisation and biocompatibility processes.
Get involved in real problem‑solving, from investigations and CAPAs to process optimisation.
Build strong relationships with external partners and suppliers, including involvement in audits.
Contribute to a culture of quality, collaboration, and accountability across the site.
Provide guidance to technicians ensuring effective daily support for ongoing tasks.

Qualifications

Degree in Engineering, Quality, or a related technical/scientific discipline.
Experience in a regulated environment (medical device or pharma), ideally within Quality or Validation.
Exposure to sterilisation processes (EO, Gamma, E-beam) or a strong interest in developing expertise in this area.
Good understanding of quality systems and regulatory requirements (ISO 13485, FDA 21 CFR Part 820).
Experience supporting or contributing to validation activities.
A naturally curious and problem‑solving mindset, with the ability to think critically.
Strong communication skills and confidence working with cross‑functional and global teams.
Someone who enjoys taking ownership and making an impact in a fast‑paced, collaborative environment.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
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