Quality Engineer II

Freudenberg Group; Galway; Hybrid; EUR 60,000 - 85,000; Full time

Job summary

Freudenberg Group in Ireland seeks an experienced Quality Assurance professional for the Medical Device division. The role focuses on identifying customer requirements, ensuring Quality System compliance, and overseeing inspection plans and CAPA processes.

Responsibilities include leading audits, coordinating investigations of quality issues, and driving continuous improvement across manufacturing and supplier activities. Strong knowledge of ISO 13485 and FDA expectations is essential.

Qualifications

• Degree/Diploma qualification in Engineering, Science and/or Quality or relevant experience in a quality assurance role within the Medical Device Industry.
• Experience in leading quality activities and problem solving.
• Knowledge of ISO 13485, FDA requirements and regulatory expectations.

Responsibilities

• Identify and document customer requirements in manufacturing documentation and ensure effective implementation.
• Maintain and audit the Quality System for compliance with customer and regulatory requirements.
• Review inspection plans and ensure their adequacy and effectiveness.
• Investigate quality issues including customer complaints and resolve using CAPA.
• Validate processes and documentation; write protocols and reports as required.
• Lead internal and supplier quality audits and support customer/regulatory audits.

Skills

Quality Assurance

Medical Device Industry

ISO 13485

FDA compliance

Six Sigma Green Belt

Lean principles

Education

Engineering/Science/Quality degree or equivalent

Job description

Working at Freudenberg

We will wow your world!

Responsibilities

• Ensure all customer requirements are identified, clearly documented in Freudenberg Medical manufacturing documentation and effectively implemented.
• Ensure the Quality System is fully compliant with customer and regulatory requirements.
• Ensure that incoming, in-process and final inspection plans are adequate and regularly reviewed for effectiveness.
• Investigate product/process quality issues that arise, including customer complaints.
• Ensure they are effectively resolved in a timely manner using the Freudenberg Medical CAPA system.
• Assess all product and manufacturing related changes, deviations and reworks, for their impact on validations, product quality and the customer.
• Make product dispositions as and when required.
• Update documentation such as specifications and visual standards to better define the quality characteristic being dispositioned.
• Ensure processes are validated in accordance with customer and Freudenberg Medical Quality System requirements.
• Write validation protocols, reports and test reports as required.
• Act as a Lead Quality Auditor.
• Perform Supplier Quality Audits.
• Act as a guide during customer and regulatory audits.
• Document manufacturing procedures, CHR's, purchasing specifications, inspection procedures and standards.
• Review and approve all updates to same.
• Use process data such as yield, output rates etc. to identify opportunities for improvement.
• Implement improvements on an ongoing basis.
• Supervise the activities of assigned staff.
• Work with customers and suppliers on quality related issues and new product introduction projects.
• Ensure all dealings are professional and good relationships are maintained at all times.
• Be part of project teams.
• Deliver on commits to schedule and budget.
• Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
• Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
• Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc).
• Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.
• To take on other duties which the Company may assign you from time to time.
• These 'other duties' will be agreed with Management prior to any assignment.

Qualifications

• Degree / Diploma qualification in Engineering, Science and/or Quality or relevant experience in a quality assurance role within the Medical Device Industry.
• A minimum of 5 years' experience in a similar role.
• Good people management skills.
• Must be able to manage a team of upto 4 staff.
• Excellent attention to detail.
• Good working knowledge of applicable regulatory requirements (ISO 13485, FDA etc.)
• Proven track record in problem solving.
• 6 sigma qualification (Green Belt of higher) required.
• Understanding of lean principles.
• Lean green belt an advantage.
• Excellent communication skills both verbal and written.
• A positive attitude in dealing with people.
• Ability to learn and adapt to various situations.
• Must be able to work under own initiative, with minimum supervision.

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.

Freudenberg Medical Ireland Ltd. Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications.

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 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.