Quality Engineer NPD
Quality Engineer (New Product Development) - Global Medical Device Organisation - Galway
The Quality Engineer - NPD will provide Quality support to our New Product Development team and specifically that of devices development.
· Participate in the new product development business as the quality voice in the development team - ensuring that quality is built into all products through all stages of the product life cycle and ensure that the project delivers an end product that meets customer expectations.
· Ensure product development process and project team achieve and maintain compliance to the Quality Management system in all aspects of the product development process
· Ensure that process and product development projects are delivered to comply with required industry process validation principles.
· Familiar with procedure and documentation generation and applying Lean principles to establishing process instructions.
· Establishing inspection standards, plans, sampling frequencies and test methods, and familiar with practical application of quality engineering tools.
· Performing reviews of established production and system procedures to identify efficiency enhancements and prevention of errors.
· Identifying and implementing effective production and process controls to maintain product quality and manufacturing effectiveness.
· Work with suppliers and customers on the resolution of product quality issues and identify quality improvement programs to sustain supplier material quality.
· Proficient in the use of quality engineering tools and ideally applying statistical software to support process investigations and identifying improvements.
· Drive continuous improvement and innovation from a quality perspective.
Key Requirements needed
· Level 8 Engineering or Science Degree.
· 3+ years’ experience in a similar role.
· Previous medical devices manufacturing development and/or manufacturing experience in an ISO13485 certified QMS environment is an advantage.
· Ability to apply a structured problem-solving approach and Six Sigma tools and methodology familiar is an advantage.
· Proficient in technical communication with excellent attention to detail is necessary.
· Experience in dealing with customers, as quality lead on projects, is an advantage.
Benefits included such as full family healthcare, pension, annual bonus
Please contact Elaine Dolan for more information or apply now.