Quality Director

Freudenberg Medical; Spiddal; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Company Pension

Health Insurance

Performance Related Bonus

Flexible Work Models

Personal Development

Job summary

Freudenberg Medical Ireland Ltd. is seeking a Quality Director to provide strategic and operational leadership for the Quality function at the Galway site.

You will ensure ISO 13485, FDA, and customer requirements are met while partnering with Operations, Engineering and Supply Chain to drive top performance in quality, delivery and customer satisfaction. The role requires a minimum of 10 years in quality within a regulated manufacturing environment, with Lean Six Sigma knowledge and SAP ERP

Qualifications

• Bachelor's degree in Science, Engineering, Manufacturing or related discipline.
• 10+ years quality experience in regulated manufacturing.
• Deep knowledge of ISO 13485 and FDA requirements.
• Experience with SAP ERP and MS Office.
• Proven cross-functional leadership and process improvement.
• Experience with Lean/Six Sigma methods.

Responsibilities

• Provide strategic and operational leadership for the Quality function.
• Lead QA QMS and regulatory compliance.
• Collaborate with Operations, Engineering and Supply Chain.
• Develop and deliver Quality Annual Operating Plan.
• Drive continuous improvement and audits readiness.
• Coach and develop Quality team.
• Assist with product transfers and validations.
• Maintain customer and supplier quality relationships.
• Lead site readiness for audits.

Skills

Quality leadership

Regulatory knowledge

Lean Six Sigma

Cross-functional collaboration

Data-driven decisions

Education

Bachelor's degree in Science/Engineering

Tools

SAP ERP

Microsoft Office

Job 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 Benefits

• Company Pension: Save for retirement with the company's help.
• Health Insurance: Rely on comprehensive services whenever you need it.
• Performance Related Bonus: When you have an impact, you can reap the rewards.
• Flexible Work Models: We allow for flexible work models to ensure both professional and personal success.
• Personal Development: We offer a variety of trainings to ensure you can develop in your career.

Spiddal, Co. Galway

On-Site

Freudenberg Medical Ireland Ltd.

Join our team as a:

Quality Director

Responsibilities

• Provide strategic and operational leadership for the Quality function, ensuring quality performance supports the site's operational and business objectives.
• Lead the site's Quality Management System, ensuring compliance with ISO 13485, FDA, customer and Freudenberg Medical requirements.
• Partner closely with Operations, Engineering and Supply Chain to drive operational excellence, improve manufacturing performance and deliver exceptional quality, delivery and customer satisfaction.
• Develop and deliver the Quality Annual Operating Plan (AOP), managing departmental performance, budgets and resources.
• Drive a culture of continuous improvement through Lean Manufacturing, Six Sigma and data-driven decision making to improve quality, efficiency and customer outcomes.
• Lead, coach and develop a high-performing Quality team, building capability, accountability and future leadership.
• Support the successful transfer, validation and launch of new products and manufacturing processes, ensuring quality is embedded from development through to production.
• Build strong relationships with customers and suppliers, proactively resolving quality issues and driving continuous improvement across the value chain.
• Lead site readiness for customer, regulatory and certification audits, ensuring ongoing compliance with all applicable quality, regulatory, health, safety and environmental requirements.
• Act as a key member of the site leadership team, contributing to business strategy, operational decision-making and the long-term growth of the Galway site.

Qualifications

• Bachelor's degree in Science, Engineering, Manufacturing or a related discipline.
• A minimum of 10 years' experience in quality within a regulated manufacturing environment.
• Strong knowledge of medical device quality and regulatory requirements, including ISO 13485, FDA and Quality Management Systems.
• Experience driving operational excellence and continuous improvement, with Lean Manufacturing and Six Sigma knowledge highly desirable.
• Proven ability to lead, influence and collaborate across cross-functional teams to deliver business and quality objectives.
• Experience with SAP ERP and proficiency in Microsoft Office applications

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.