Quality Engineer (Fixed Term Contract)

Freudenberg Medical; Connacht; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Flexible Work Models

Health Insurance

Diversity & Inclusion

Personal Development

Company Pension

Job summary

Freudenberg Medical Ireland Ltd. is seeking a Quality Engineer on a fixed-term contract to support delivery of high-quality medical devices. You will work with Manufacturing and Engineering to ensure regulatory and customer requirements are met.

The role involves validation, CAPA, change control, product release support, and participation in internal audits and supplier quality activities, applying ISO 13485 and FDA guidelines. A collaborative, hands-on approach is essential.

Qualifications

• Bachelor’s degree in Engineering, Science, Quality or Manufacturing, ideally with a Medical Device emphasis.
• 2–3 years’ experience in a Quality or Validation Engineering role within a regulated manufacturing environment.
• Knowledge of ISO 13485 and FDA requirements; QMSR knowledge is an advantage.

Responsibilities

• Support delivery of high-quality medical devices with Manufacturing and Engineering to ensure regulatory and customer requirements are met.
• Play active role in new product introductions and change control to ensure proper implementation.
• Coordinate and support validation activities, including preparation, execution and maintenance of validation documentation.

Skills

Analytical skills

Problem solving

Cross-functional teamwork

Communication

Education

Engineering degree

Medical Device emphasis

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

• Flexible Work Models: We allow for flexible work models to ensure both professional and personal success.
• Health Insurance: Rely on comprehensive services whenever you need it.
• Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.
• Personal Development: We offer a variety of trainings to ensure you can develop in your career.
• Company Pension: Save for retirement with the company's help.

Carrick-on-Shannon, Co. Leitrim

On-Site

Freudenberg Medical Ireland Ltd.

Join our team as a:

Quality Engineer (Fixed Term Contract)

Responsibilities

• Support the delivery of high-quality medical devices by working closely with Manufacturing, Engineering and other teams to ensure products meet customer and regulatory requirements.
• Play an active role in new product introductions and change control, ensuring products and processes are introduced effectively and in line with quality requirements.
• Coordinate and support validation activities, including the preparation, execution and maintenance of validation documentation and programmes.
• Investigate product and process issues, using structured problem-solving and data analysis to identify root causes and implement effective corrective actions.
• Support the site’s Quality Management System, ensuring compliance with ISO 13485, FDA 21 CFR Part 820 QMSR and applicable European medical device regulations.
• Review and release batch documentation, ensuring product release requirements are met.
• Manage and support customer complaint investigations, CAPA activities and product-related quality issues, including vigilance and recall activities where required.
• Participate in internal audits, supplier quality activities and the maintenance of calibration and other quality programmes.
• Use quality data, trending and continuous improvement tools to identify opportunities to improve processes, reduce waste and strengthen quality performance.

Qualifications

• Bachelor’s degree in Engineering, Science, Quality, Manufacturing or a related discipline, ideally with a Medical Device or Biomedical emphasis.
• Approximately 2-3 years’ experience in a Quality or Validation Engineering role within a medical device, pharmaceutical or similarly regulated manufacturing environment.
• Experience working with Quality Management Systems and an understanding of ISO 13485 and applicable FDA requirements; knowledge of FDA 21 CFR Part 820 QMSR is an advantage.
• Practical experience in one or more areas such as validation, CAPA, change control, complaint investigations, product release or new product introduction.
• Strong analytical and problem-solving skills, with the ability to investigate issues, interpret data and drive practical solutions.
• A collaborative, hands-on approach, with the ability to work effectively across teams and communicate clearly with a range of stakeholders.

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.