Job title:Design Quality Assurance Engineer
Location: Ballybrit Upper Industrial Estate, Galway
Benefits:Top salary, Pension, healthcare, yearly bonus, 4 day week.


Client:
My client are the global expert in the design, development, and manufacturing of complex medical devices and component technologies



Role overview:
As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected. As a Design Quality Assurance Engineer you will be responsible for assuring product quality, safety and effectiveness.



Responsibilities:

• As a lead Quality Engineer on projects, directly contributing and/or providing guidance to others to establish quality documentation. Providing detailed planning for pilot production and scale-up plans in New Product Introduction programs.
• Ensuring project teams are utilizing Medical Quality Systems and appropriate regulations and industry standards throughout the product development process.
• Conducting risk assessments of the design to determine ability to function as intended.
• Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and vendor audits, product release, document control, design control process and design history files (DHF), device master records, etc.
• Interacting with customer and supplier companies in a professional manner; proactively communicating with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.
• Intervening and contributing to successful resolution of technical issues when they arise.
• Ensuring that all work satisfies the requirements of the company's Quality Management System.
• Leading Quality roles on client programs, assisting in the design and implementation of new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation.

• Minimum Bachelor's degree in Engineering or related field.
• 3 years of medical device design and development/quality assurance experience is required.
• Managing customer relationships and responses in aa timely manner.
• Ability to interact with client companies in a professional manner.
• Demonstrated ability to lead product verification & validation activities
• Experience working with operations to develop strong manufacturing process instructions is desired.
• Familiarity with FDA QSRs, medical device regulations and ISO 13485