Design Quality Assurance Specialist

2 weeks ago

Galway, Galway, Ireland beBeeQuality Full time €65,433 - €98,326

Job Summary:

A Design Quality Assurance Engineer is required to join our team in Galway, Ireland. 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.

Key Responsibilities:
  • Assure product quality, safety and effectiveness
  • Provide detailed planning for pilot production and scale-up plans in New Product Introduction programs
  • Ensure project teams are utilizing Nordson 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), device master records etc.
Requirements:
  • Minimum Bachelor's degree in Engineering or related field
  • 3 years of medical device design and development/quality assurance experience required
  • Managing 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
  • Experience working with operations to develop strong manufacturing process instructions is desired
  • Familiarity with FDA QSRs, medical device regulations and ISO 13485
  • Knowledge of probability and statistics
  • Organised and able to self-manage project tasks
  • Customer focus with excellent communication skills, written and oral
  • Experience using an electronic quality management system (eQMS) a plus
  • Lean or Six Sigma certification/experience
  • Auditor experience preferred (i.e Supplier, Customer, Third Party, Quality Management System (QMS))
  • Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit

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