Quality Manager

Freudenberg Medical; Spiddal; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Company Pension

Health Insurance

Performance Related Bonus

Flexible Work Models

Diversity & Inclusion

Job summary

Freudenberg Medical Ireland Ltd. in Spiddal is seeking a Quality Manager to lead the Quality team and uphold ISO 13485 and FDA readiness across the site.

You will drive continuous improvement, partner with Engineering and Manufacturing, own the QMS, and lead audits while delivering measurable quality enhancements for medical devices throughout the product lifecycle. This is a hands-on leadership role with strategic oversight and cross-functional collaboration.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing or related.
• Minimum of 10 years' progressive experience in a manufacturing environment, ideally medical devices.
• At least 3 years' experience directly managing and developing employees.
• Strong knowledge of ISO 13485 and applicable FDA requirements.
• Expertise in CAPA, complaint handling, internal auditing, change management and validation.
• Experience applying Lean, Six Sigma and QA methodologies.
• Proficient in data analysis and statistical tools (e.g., Minitab).
• Excellent communication and cross-functional leadership.

Responsibilities

• Lead and develop the Quality team, driving high standards of quality, continuous improvement and customer satisfaction across the site.
• Take ownership of the site's Quality Management System, ensuring compliance with ISO 13485, applicable FDA requirements and customer expectations.
• Act as Management Representative for the QMS, providing leadership and oversight across key quality processes.
• Partner with Engineering, Manufacturing and other teams to provide expert quality input into problem-solving, change management, validation and product disposition.
• Lead customer and regulatory audits, ensuring the site is audit-ready and driving effective follow-up actions.
• Oversee supplier quality and work closely with customers and suppliers to resolve issues and deliver sustainable improvements.
• Champion structured problem-solving and data-driven decision‑making to strengthen quality performance and prevent recurrence.
• Lead quality improvement projects from concept through to delivery, ensuring measurable results are achieved on time and within budget.
• Build strong relationships across the business, influencing stakeholders and supporting the delivery of high-quality medical devices throughout the product lifecycle

Skills

Quality leadership

Data analysis

Problem-solving

Team management

Regulatory knowledge

Stakeholder communication

Continuous improvement

Education

Bachelor's degree in Engineering/Quality/Manufacturing

Tools

Minitab

QMS awareness

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.

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.
• 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.

Quality Manager

Responsibilities

• Lead and develop the Quality team, driving high standards of quality, continuous improvement and customer satisfaction across the site.
• Take ownership of the site's Quality Management System, ensuring compliance with ISO 13485, applicable FDA requirements and customer expectations.
• Act as Management Representative for the QMS, providing leadership and oversight across key quality processes.
• Partner with Engineering, Manufacturing and other teams to provide expert quality input into problem-solving, change management, validation and product disposition.
• Lead customer and regulatory audits, ensuring the site is audit-ready and driving effective follow-up actions.
• Oversee supplier quality and work closely with customers and suppliers to resolve issues and deliver sustainable improvements.
• Champion structured problem-solving and data-driven decision‑making to strengthen quality performance and prevent recurrence.
• Lead quality improvement projects from concept through to delivery, ensuring measurable results are achieved on time and within budget.
• Build strong relationships across the business, influencing stakeholders and supporting the delivery of high-quality medical devices throughout the product lifecycle

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing or a related discipline.
• Minimum of 10 years' progressive experience in a relevant manufacturing environment, ideally within medical devices or another highly regulated industry.
• At least 3 years' successful experience directly managing and developing employees, including performance management, coaching and team development.
• Strong knowledge of medical device Quality Management Systems, ISO 13485 and applicable FDA regulatory requirements.
• Proven expertise across core quality processes, including CAPA, complaint handling, internal auditing, change management and validation.
• Experience applying Lean, Six Sigma and Quality Assurance methodologies to deliver practical, sustainable improvements.
• Strong analytical and problem‑solving skills, with the ability to interpret data and apply statistical tools such as Minitab.
• Confident communicator and collaborative leader, able to influence at all levels and build effective relationships with customers, suppliers and regulatory agencies.
• A hands‑on, improvement‑focused approach, with the ability to balance strategic quality leadership with the practical needs of a busy manufacturing 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.