Senior Design Assurance Project Lead

4 days ago

Galway, Galway, Ireland beBeeQualityManagement Full time €60,000 - €80,000
Job Title: Project Manager Design Assurance

Job Summary:

This role involves leading quality representatives on projects, contributing to and providing guidance to others in establishing appropriate Design History File/Device Master Record documentation.

Key Responsibilities:

  • Develop detailed plans for clinical, pilot production, and scale-up processes in New Product Introduction programs.
  • Evaluate the use of Nordson Medical Quality Systems and relevant regulations and industry standards throughout product development.
  • Investigate material biocompatibility and suitable sterilization methods during the product design cycle.
  • Conduct risk assessments of the design to ensure it functions as intended.
  • Maintain timely Corrective and Preventative Actions (CAPA), change control, and notification procedures for internal and vendor audits, product releases, document control, design control process, and design history files (DHF).
  • Interact with customer and supplier companies professionally, ensuring ongoing two-way communication.
  • Resolve technical issues when they arise and contribute to their successful resolution.
  • Ensure all work satisfies the company's Quality Manual requirements.
  • Foster a culture of continuous improvement and compliance.

Requirements:

  • Minimum Bachelor's degree in Engineering or related field.
  • 6+ years of medical device design and development/quality assurance experience is required.
  • Effective management of customer relationships and responses.
  • Ability to interact with client companies professionally.
  • Demonstrated ability to lead product verification & validation activities.

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