Our client is a global leader in Medical Devices and Diagnostics and is going through an extremely exciting time at the moment, with two NPI's happening on site in their North Dublin facility.
The quality function works cross-functionally with engineering, production and procurement to cover a wide area of responsibilities such as Change Management, Inspections/ Regulatory Audits with respect to design change, product development and design controls, Verification, Validation and Risk Management.
There is an opening for an SME Design Quality professional who will focus on the application of Design Controls while supporting the development and design change teams in accordance with regulatory expectations and company procedures.
Some role responsibilities will include:
- Ensures the comprehensive completion of risk management, Design Verification, Process Validation, and Design Validation activities for products and processes
- Supports the development and validation of appropriate test methods for product and process performance
- Ensures active and thorough investigation of quality issues and effective corrective and/or preventive action
- Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results
- As the SME, capable of providing competent Supplier Quality audit support with respect to the implementation of all Design Controls elements
- Participates as subject matter expert during regulatory inspections.
- 8 or more years relevant experience supporting the development and/or sustaining engineering associated with IVD hardware systems in a regulated environment with a core appreciation of FDA regulations and specifically the implementation and application of design controls.
- Strong leadership skills and ability to influence cross functional teams to drive work scope to compliant and successful completion.
- Self-starter, bias for action with ability to support projects through to completion. Good organization skills.
To discover more about this opportunity, apply now or contact Helena Boyle on (01) 6321870/0873360953 for a confidential discussion.