Senior Quality Assurance Strategist

2 weeks ago

Galway, Galway, Ireland beBeeQuality Full time €70,000 - €85,000
Job Title: Design Assurance Program Manager

Key Responsibilities:

  • Lead Quality Representative on projects, contributing and/or providing guidance to establish appropriate Design History File / Device Master Record documentation.
  • Ensure project teams utilize Quality Systems and appropriate regulations and industry standards throughout the product development process.
  • Investigate and evaluate material biocompatibility and appropriate methods of sterilization during the product design cycle.
  • Conduct risk assessments of the design to determine the 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.
  • Interact with customer and supplier companies in a professional manner; proactively communicate to ensure an ongoing two-way exchange of information.
  • Intervene and contribute to the successful resolution of technical issues when they arise.
  • Ensure that all work satisfies the requirements of the Quality Manual.
  • Continually look for improvement and compliance opportunities.
  • Lead Quality roles on client programs, assisting in the design and implementation of new methodologies, materials, machines, processes, or products to bring concepts to market, including essential product and process documentation.

Requirements:

  • Bachelor's degree in Engineering or related field required.
  • 6+ years medical device design and development/quality assurance experience is required.
  • 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.
  • Experience working with operations to develop strong manufacturing process instructions and operator training desired.

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