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.
Desired Skills and Experience
Mid‑Senior level professional with 5+ years of experience in design quality engineering for medical devices, including regulatory compliance, validation activities, and new product development within regulated manufacturing environments.
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