Quality Systems Lead - Medical Device QA & Audit

Freudenberg; 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

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.