My client a growing medical device company are looking for a Quality Engineer to enhance their growing team
Quality Engineer- Medical Device- Dublin
My client a growing medical device company are looking for a Quality Engineer to enhance their growing team. As a Quality Engineer, you'll provide support to the Operations, Engineering and Quality Management functions. You will lead the development of Design and Development processes in-line with Medical Device Regulations for global markets and jurisdictions.
- Support product design and manufacturing activities
- Represent Quality through all product and process development life cycle phases to help ensure product manufacturability, reliability and cost effectiveness.
- Provide advice based on R&D's objectives
- Create, manage and maintain and Medical Device Files, Technical Files and Risk Management files.
- Review engineering specifications to ensure QA requirements are met
- Make sure that equipment and process validations meet FDA, Canadian and EU regulatory requirements
- Prepare reports, documents, procedures, specification's and other such technical documents as required to ensure the success of the project
- Drives compliance cross-functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification
Education and Experience:
- A Bachelor's degree in engineering or a related field
- At least three years' experience in a similar role in the medical device industry, experience in In-Vitro Diagnostic Medical Devices advantageous.
- Experience in Medical Device Design and Development processes
- Experience in Risk Management processes.
- Experience of validating processes to medical device regulatory requirements
- Project management experience
- Knowledge of analytical and statistical techniques, including SPC and inspection and test methodologies
- The ability to develop and write protocols, validation reports and engineering reports
- Competent working knowledge of recognized Quality Management Systems (e.g. ISO13485),
- Awareness of relevant laws and regulations (e.g. MDD/ FDA/ PAL)
- Broad knowledge of engineering and technical applications applied in the development of medical devices.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.