A leader in their specialist segment, this organisation houses research, product development and manufacturing of medical devices to FDA approved standards. From their site in Dublin the company distributes to more than 50 countries across the globe and is unique in its product offering for the business. They are seeking a talented Systems Engineer to join their team on site.
Reporting to the Quality Assurance Manager this role will be responsible for ensuring appropriate quality systems are in place facilitating the production of quality products in the most efficient manner possible, other responsibilities will include:
- Provide Quality support to manufacturing and test of medical instrumentation product platforms in a low volume, high complexity and highly regulated technology environment.
- Capability to analyse problems to root cause with a structured approach and fully develop solutions, including all associated planning and design validation activity.
- Incumbent may be a member of several project teams working with Manufacturing Engineering, CPE, Q.A., R&D, Service and Continuous Improvement.
- Maintain a customer focus at all times, ensuring that the company is aligned to customer expectations. This includes internal and external customers.
- Ability to use lean tools to improve existing processes so they remain compliant and facilitate the production of quality products in an efficient manner.
- The successful candidate will have experience in compiling and reviewing technical reports to meet technical and regulatory standards of excellence, covering a broad range of activities, including verification, validation of product and process changes, risk assessment, technology transfer plans, equipment commissioning, deviations, corrective and preventative actions documents.
- An understanding of statistical methodology to support process control & monitoring, process validations and/or process characterisation.
- Minimum of an undergraduate degree, ideally an advanced degree in related Engineering or Scientific discipline.
- 2 years QA experience within the Biotechnology or Medical Device industry.
- Eligible to work and live within the EU.
- Family Healthcare.
- Onsite GYM.
- Subsidised Canteen.
To learn more, apply online or contact Preneta directly on +353 1 6321870 for a confidential discussion.
Salary: On Application
Location: Dublin City Centre