Quality Manager - Medical Devices & QMS Excellence

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

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.