Quality Engineer II

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 BenefitsFlexible 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. Spiddal, Co. Galway On-Site Freudenberg Medical Ireland Ltd You will support our team as a Quality Engineer IIResponsibilities

• Join our Quality Assurance team in Spiddal as a hands-on Quality Engineer II, supporting manufacturing, validation, audits and continuous improvement to ensure compliant, high-quality medical devices.
• Ensure customer and regulatory requirements are clearly defined, documented and embedded into manufacturing processes, maintaining compliance with the Quality Management System and applicable standards.
• Develop, review and maintain effective incoming, in-process and final inspection plans, making product disposition decisions and updating specifications and visual standards as required.
• Lead investigations into product and process quality issues, including customer complaints, driving timely and effective resolution through the CAPA system and assessing deviations, reworks and manufacturing changes for impact on product quality and validation status.
• Lead and support process validations in line with customer and internal requirements, including authoring and approving validation protocols, reports and test documentation.
• Review and approve manufacturing procedures, CHRs, purchasing specifications and inspection standards.
• Act as Lead Quality Auditor, conducting supplier quality audits and supporting customer and regulatory inspections.
• Analyse process performance data to identify trends and drive continuous improvement initiatives.
• Supervise and support assigned team members and contribute to project teams, delivering agreed milestones to schedule and budget.

Qualifications

• Degree or Diploma in Engineering, Science, Quality or equivalent experience in a Quality Assurance role within the Medical Device industry.
• Minimum of 5 years’ experience in a similar quality engineering role.
• Proven experience supervising or leading small teams
• Strong working knowledge of ISO 13485, FDA and related regulatory standards.
• Demonstrated problem-solving capability with Six Sigma Green Belt (or higher) certification.
• Understanding of Lean principles; Lean Green Belt is an advantage.
• Excellent attention to detail with strong analytical, communication and decision-making skills.
• Proactive, adaptable and comfortable working with minimal supervision.
• Must be able to work under own initiative, with minimum supervision.

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.