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, Co. Galway, on site, is seeking a Quality Manager to lead the quality team and drive the site’s quality management system for medical devices. You will ensure regulatory compliance and partner with engineering and manufacturing to deliver high-quality products.

The role requires extensive experience in quality management within regulated manufacturing, with a hands-on, improvement-focused leadership style to achieve measurable outcomes.

Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing or related field.
• 10+ years in manufacturing, ideally medical devices.
• 3+ years in people management and coaching.

Responsibilities

• Lead the Quality team and uphold site quality standards.
• Own the QMS and ensure ISO 13485 compliance.
• Act as Management Representative for the QMS and lead audits.
• Collaborate with Engineering & Manufacturing on CAPA & change management.
• Lead customer and regulatory audits with effective follow-up actions.
• Oversee supplier quality and issue resolution.
• Drive structured problem-solving and data-driven improvements.
• Build relationships with customers, suppliers and regulatory bodies.

Skills

Quality leadership

Regulatory knowledge

ISO 13485

CAPA management

Auditing

Lean Six Sigma

Data analysis

Stakeholder influence

Education

Bachelor's degree in Engineering or related

Six Sigma certification

Tools

Minitab

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.
• 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.

Join our team as a: 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.