Quality Engineer II - Medical Devices (Flexible Work Models)

Freudenberg Medical, LLC; Spiddal; Sur place; EUR 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

Company Pension

Health Insurance

Flexible Work Models

Personal Development

Diversity & Inclusion

Résumé du poste

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

You will partner with Manufacturing and Engineering teams to drive CAPA, lead process validations, support NPI initiatives, and contribute to audits while coaching junior quality staff to strengthen operations and compliance.

Qualifications

• ISO 13485 and FDA quality systems knowledge.
• CAPA, root-cause investigation and structured problem-solving.
• Six Sigma Green Belt or higher with Lean principles.
• 5+ years in Quality Engineering/Quality Assurance, preferably Medical Device.
• Leadership or mentoring experience.

Responsabilités

• Take ownership of quality activities across manufacturing and ensure customer and regulatory requirements are met.
• Be a key contact for quality issues, working with Manufacturing and Engineering to investigate problems, resolve customer complaints and drive 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 quality expertise to determine impact and disposition.
• Get involved in audits, including opportunities to act as Lead Quality Auditor.
• Use quality and manufacturing data to spot trends and identify improvement opportunities.

Connaissances

Quality engineering

CAPA

Root-cause analysis

Lean principles

Leadership experience

Formation

Engineering/Science degree

Description du poste

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

You will partner with Manufacturing and Engineering teams to drive CAPA, lead process validations, support NPI initiatives, and contribute to audits while coaching junior quality staff to strengthen operations and compliance.