Lead Design QA Engineer – Medical Devices & NPD

Hero Recruitment Group; Galway; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Hero Recruitment Group is seeking a Design Quality Assurance Engineer in Ireland to provide quality leadership across the product development lifecycle for medical devices. The role focuses on design controls, risk management, QMS compliance, supplier engagement and continuous improvement to ensure safe and effective products reach the market.

The ideal candidate will have a Bachelor's degree in Engineering and at least 3 years of medical device QA/design experience, with strong documentation,

Qualifikationen

• Bachelor’s degree in Engineering or related field.
• 3 years of medical device design and development/quality assurance experience.
• Experience with quality management systems (QMS) and regulatory standards.
• Familiarity with FDA QSRs and ISO 13485.
• Strong documentation and audit skills.

Aufgaben

• Lead quality activities on client programs and drive documentation.
• Manage CAPA, change control, and audits (internal, supplier, regulatory).
• Oversee design controls, DHF, and device master records.
• Coordinate with suppliers and customers to meet timelines.
• Support continuous improvement and risk management.
• Ensure compliance with QMS and regulatory requirements.
• Lead verification and validation activities.
• Maintain detailed development documentation.
• Facilitate regulatory audits and QMS training.

Kenntnisse

Regulatory compliance

Quality systems

Risk management

Design controls

CAPA management

Auditing

Supplier management

Documentation

Project leadership

Ausbildung

Bachelor's degree in Engineering or related field

Tools

eQMS

Jobbeschreibung

Hero Recruitment Group is seeking a Design Quality Assurance Engineer in Ireland to provide quality leadership across the product development lifecycle for medical devices. The role focuses on design controls, risk management, QMS compliance, supplier engagement and continuous improvement to ensure safe and effective products reach the market.

The ideal candidate will have a Bachelor's degree in Engineering and at least 3 years of medical device QA/design experience, with strong documentation,