Quality Engineer

Design Quality Engineer | 12 Month FTC

A global medical device manufacturer is seeking a Design Quality Engineer to join its team supporting new product development and product introduction activities within a highly regulated environment. This role offers the opportunity to work closely with R&D, Engineering and Quality teams on innovative medical technologies while ensuring compliance with global quality and regulatory standards.

Key Responsibilities

• Support New Product Development (NPD) and New Product Introduction (NPI) projects
• Maintain and govern product risk management files
• Support validation activities including process, equipment, software and test method validation
• Conduct risk assessments, process capability studies and component qualifications
• Support product verification, reliability testing and statistical analysis
• Participate in audits and support regulatory submissions
• Collaborate cross-functionally to support successful product launches and continuous improvement initiatives

Requirements

• Degree qualified in Engineering, Science or related discipline
• Minimum 3 years' experience within Class II or III medical devices
• Strong knowledge of ISO 13485, ISO 14971, MDR, MDSAP and FDA QSR requirements
• Experience within highly regulated manufacturing environments
• Strong analytical, problem-solving and communication skills

This is an excellent opportunity to join a leading organisation offering exposure to innovative projects, collaborative teams and long-term career development within the medical device sector.

Apply now or call Kerry on 086 044 3981 for more information.