Product Development Quality Leader

3 days ago


Galway, Galway, Ireland beBeeProgram Full time €90,000 - €105,000

Job Title: Design Assurance Program Manager

Location: Ballybrit Upper Industrial Estate, Galway

Key Responsibilities:
  • Lead Quality Representative on projects and provide guidance to others for establishing appropriate Design History File / Device Master Record documentation.
  • Provide detailed planning for clinical, pilot production, and scale-up plans in New Product Introduction programs.
  • Ensure project teams utilize relevant regulations and industry standards throughout the product development process.
  • Investigate and evaluate material biocompatibility and sterilization methods during product design.
  • Conduct risk assessments of the design to determine functionality.
  • Responsible for timely Corrective and Preventative Actions (CAPA), change control, internal and vendor audits, product release, document control, and design control process.
  • Auditing and qualification of new suppliers may be required.
  • Ensure all work satisfies the company's Quality Manual requirements.
Requirements:
  • Minimum Bachelor's degree in Engineering or related field.
  • 6+ years of medical device design and development/quality assurance experience.
  • Ability to lead product verification & validation activities.


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