Quality Director

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.

Benefits include:

• Company Pension: Save for retirement with the company's help.
• 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.
• Performance Related Bonus: When you have an impact, you can reap the rewards.
• Personal Development: We offer a variety of trainings to ensure you can develop in your career.

Location: Spiddal, Co. Galway
Work Arrangement: On-Site
Company: Cambus Teoranta

Position: Quality Director

Responsibilities:

1. Lead the Quality & Regulatory function, setting strategy and aligning with annual operating plans (AOP) and global objectives.
2. Own the Quality Management System (QMS), ensuring compliance with ISO13485, FDA, and Freudenberg Medical standards.
3. Define and track key quality metrics to drive efficiency, effectiveness, and competitive advantage.
4. Deliver Management Reviews, providing objective evaluations, performance insights, and improvement actions.
5. Drive flawless product and process launches, partnering with NPI teams and customers to ensure compliance and success in production.
6. Work closely with customers to resolve quality issues, ensuring all products meet specifications and industry standards.
7. Lead supplier quality programs, implementing best practices and building strong, collaborative relationships.
8. Promote a culture of quality ownership, educating employees on regulations, systems, and their role in compliance.
9. Develop and mentor the Quality team, building capabilities, advancing skills, and supporting professional growth.
10. Champion Operational Excellence, HS&E compliance, and continuous improvement initiatives, delivering projects on time and within budget.

Qualifications:

• Bachelor's degree in Science, Engineering, Manufacturing, or related field.
• Thorough knowledge of medical devices quality systems (ISO13485/FDA).
• Knowledge of LEAN and Six Sigma methodologies is desirable.
• A minimum of ten (10) years of relevant progressive experience within a similar environment, with five or more successful years in a leadership position.
• Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA, etc.).
• Experience using SAP ERP software and proficiency in Microsoft Office Suite.
• Demonstrable ability to achieve goals through collaboration, influencing, and interaction at all levels across the business/function.

The Freudenberg Group is an equal opportunity employer 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, ethnicity, age, disability, genetic information, marital status, sexual orientation, protected military or veteran status, or any other characteristic protected by law.