Quality Engineer II

Freudenberg Medical, LLC; 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. 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.

Responsibilities

• 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.

Skills

Quality engineering

CAPA

Root-cause analysis

Lean principles

Leadership experience

Education

Engineering/Science degree

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.

Flexible Work Models: We allow for flexible work models to ensure both professional and personal success.

Personal Development: We offer a variety of trainings to ensure you can develop in your career.

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 Engineer II

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.

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.

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.