Quality Engineer – Operations (Location: Galway, Ireland)
As quality engineer at WhiteSwell, you will ensure the quality of innovative devices to advance clinical care for heart failure patients. You are a proactive self-starter who communicates well with multi-disciplinary teams.
Join WhiteSwell, a dynamic, rapidly growing organisation, as we seek to fundamentally shift treatment of acute decompensated heart failure by harnessing the vital role of the lymphatic system in restoring fluid balance.
What you’ll do:
- As part of the Quality and Regulatory affairs teams, you will be responsible for supporting WhiteSwell Operations to ensure manufacturing and delivery of compliant product.
- Develop, implement and manage comprehensive inspection procedures.
- Manage and implement procedures for non-conforming product.
- Develop and maintain PFMEA and provide direction in the development of validation protocols and reports.
- Review DHR records and prepare product release documentation.
- Prepare quality system metrics on a pre-determined basis to support management meetings and for management review.
- Implement the CAPA system at WhiteSwell ensuring that comprehensive root cause analysis is completed and that corrective and preventive actions are effectively implemented.
- Support the supplier management programme ensuring that all sub-contractors, suppliers, and external parties meet and adhere to the requirements of the WhiteSwell quality system.
What you bring:
- A Bachelor’s degree in Science or Engineering
- A minimum of two years’ experience in a quality engineering or regulatory role ideally in a regulated environment. Medical device industry experience is an advantage.
- High level of self-motivation and the ability to deliver the work required to advance the company goals with a minimal amount of direction.
- Excellent written, interpersonal communication and presentation skills.
- A clear sense of ownership and accountability in meeting commitments, following through, and taking personal responsibility for decisions, actions and failures.