Job Summary
This is an exciting opportunity to join a leading multinational Medical Device organization based in Dublin. The ideal candidate will be able to support new product design and development, ensuring compliance with regulatory standards.
Duties
* Support new product design and development, working closely with Device Engineering through the entire product life cycle.
* Design control compliance, ensuring consistent planning, development, testing, and change management.
* Regulatory compliance: ensuring product development and maintenance in accordance with FDA QSR's, ISO 13485, EU MDR, CMDR, MDD, J-PAL, IEC 62304 and relevant guidance documents.
* Design risk management, assuring appropriate and consistent risk management tool use for all programs and projects.
* Supervision of and contribution to pre- and post-market risk assessments.
* Interact with other functions as necessary.
* Perform internal and supplier audits.
* Lead personnel within the Quality organization in support of the business need.
* Supplier qualification, vendor management and performance evaluation.
Requirements
* Bachelor degree in science, microbiology, engineering or equivalent technical field with 8+ years of applicable industry experience, or MS with 4+ years of applicable industry experience.
* Experience in medical device design control including software development and product realization.
* Competence in statistical tools including design of experiments and sampling methods.
* Experience in design quality assurance, risk management.
* Problem solving skills e.g root cause analysis and CAPA implementation.
* Understanding of one or more subsystem technologies: electrical, mechanical pneumatic and / or software systems.
* Understanding of human factors and user-interface design.
* Knowledge of medical device regulations including FDA, GMP, design controls, ISO 13485, EU MDR, IEC 62304, ISO 14971, etc.
* Lead auditor certification.
* Experience in supplier management.