Senior Product Development Specialist

2 weeks ago


Galway, Galway, Ireland beBeeQuality Full time €75,000 - €95,000

Job Title: Design Quality Assurance Engineer

Location: Ballybrit Upper Industrial Estate, Galway

As a key 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 ensuring product quality, safety, and effectiveness.

Key Responsibilities:
  • Lead Quality Engineer on projects, directly contributing and/or providing guidance to others to establish quality documentation.
  • Ensure project teams are utilizing Medical Quality Systems and appropriate regulations and industry standards throughout the product development process.
  • Conduct 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).
  • Interact with customer and supplier companies in a professional manner; proactively communicate with them to ensure an ongoing two-way exchange of information.
  • Intervene and contribute to successful resolution of technical issues when they arise.
  • Ensure that all work satisfies the requirements of our Quality Management System.
Requirements:
  • Bachelor's degree in Engineering or related field.
  • Minimum 3 years of medical device design and development/quality assurance experience.
  • Manage customer relationships and responses in a timely manner.
  • Ability to interact with client companies in a professional manner.
  • Demonstrated ability to lead product verification & validation activities.


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