Quality Engineer II - Medical Devices & NPI Leader

Freudenberg Medical; Spiddal; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Company Pension

Health Insurance

Flexible Work Models

Personal Development

Diversity & Inclusion

Job summary

Freudenberg Medical Ireland Ltd. in Spiddal, Co. Galway, is seeking a Quality Engineer II to own quality activities across manufacturing, ensuring customer and regulatory requirements are understood and met.

You will lead CAPAs, support NPI, audits, and drive continuous improvement while mentoring a quality team and collaborating with Manufacturing, Engineering and Operations in a busy medical device environment.

Qualifications

• Around 5+ years' Quality Engineering/Quality Assurance experience, ideally within the Medical Device industry.
• Degree/Diploma in Engineering, Science, Quality or a related discipline, or equivalent relevant industry experience.
• Good working knowledge of ISO 13485, FDA requirements and medical device Quality Systems.
• Strong hands-on experience in CAPA, root-cause investigation, validation and structured problem-solving.
• Six Sigma Green Belt or higher, with an understanding of Lean principles.
• Some previous experience leading, supervising or mentoring others, or readiness to take the next step into people management.
• Confident communicator who can build effective relationships with customers, suppliers and cross-functional teams.
• Practical, adaptable and detail-focused, with a genuine interest in continuous improvement.

Responsibilities

• Take ownership of quality activities across manufacturing, ensuring customer and regulatory requirements are understood and consistently met.
• Be a key point of contact for quality issues, working with Manufacturing and Engineering teams to investigate problems, resolve customer complaints and drive effective CAPAs.
• Play an active role in new product introduction (NPI), partnering with customers, suppliers and internal project teams from development through to production.
• Lead and support process validation, including validation protocols, reports and associated quality documentation.
• Assess manufacturing changes, deviations and rework, using your quality expertise to determine impact and appropriate product disposition.
• Get involved in customer, regulatory and supplier audits, including opportunities to act as Lead Quality Auditor.
• Use quality and manufacturing data to spot trends, identify improvement opportunities and help strengthen processes.
• Lead and support assigned Quality team members, providing coaching and day-to-day guidance while working closely with colleagues across Quality, Engineering, Manufacturing and Operations.

Skills

Quality engineering

CAPA & root-cause analysis

ISO 13485 & FDA

Six Sigma Green Belt

Leadership / mentoring

Problem solving

Cross-functional collaboration

Education

Engineering/Science degree

Quality-related qualification

Job description

Freudenberg Medical Ireland Ltd. in Spiddal, Co. Galway, is seeking a Quality Engineer II to own quality activities across manufacturing, ensuring customer and regulatory requirements are understood and met.

You will lead CAPAs, support NPI, audits, and drive continuous improvement while mentoring a quality team and collaborating with Manufacturing, Engineering and Operations in a busy medical device environment.