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Associate qa engineer

Shannon
Freudenberg Medical
Qa engineer
Posted: 23 January
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: precision molding and extrusions, complex catheters, hypotubes, and coatings.Some of your BenefitsCompany Pension:Save for retirement with the company's help.Health Insurance:Rely on comprehensive services whenever you need it.Flexible Work Models:We allow for flexible work models to ensure both professional and personal success.Diversity & Inclusion:We focus on providing an inclusive environment and recognize our diversity contributes to our success.Personal Development:We offer a variety of trainings to ensure you can develop in your career.Carrick-on-Shannon, Co. LeitrimOn-SiteFreudenberg Medical Ireland Ltd.You will support our team as a:Associate QA Engineer (Validation)ResponsibilitiesLearn and apply quality system requirements to support the development, validation, and manufacture of life-changing medical devices.Use statistical tools and data analysis to support project teams and build strong problem-solving skills.Support the creation of validation documentation, including Master Validation Plans and IQ/OQ/PQ protocols and reports.Contribute to risk management activities, design reviews, and core quality documentation.Assist with investigations into nonconformances, complaints, and CAPAs, helping to drive real improvements.Support internal and external audits and learn how quality systems operate in a regulated environment.Take part in Measurement System Analysis (MSA), including Gage R&R and test method validations.Work closely with cross-functional teams and gain exposure across engineering, manufacturing, and R&D.QualificationsBachelor's degree in Engineering, Chemistry, Biology, or a related technical/scientific discipline.0-3 years' experience in medical devices or another regulated industry (graduates welcome).Basic knowledge of quality and statistical tools such as DOE, FMEA, Control Plans, MSA, SPC, and GD&T.A curious mindset with strong problem-solving, analytical, and critical-thinking skills.Understanding of ISO standards (ISO 13485, ISO 14001, ISO or a willingness to learn.Awareness of GMP principles and regulatory requirements (e.g., 21 CFR 820).Interest in design control, validation, and verification processes.A proactive attitude and desire to build a long-term career in Quality at Freudenberg Medical.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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