Senior Quality Assurance Manager

2 days ago

Galway, Galway, Ireland beBeeQuality Full time €90,000 - €100,000

Job Title: Senior Quality Assurance Manager

We are seeking a highly skilled and experienced quality assurance manager to lead our medical device design and development efforts.

Key Responsibilities:
  • Lead Quality Representative on projects, ensuring that all products meet the highest standards of quality and compliance.
  • Collaborate with project teams to implement Nordson Medical Quality Systems and relevant 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 its ability to function as intended.
  • Ensure 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:

  • Bachelor's degree in Engineering or related field.
  • 6+ years of medical device design and development/quality assurance experience.
  • Ability to interact with client companies in a professional manner.
  • Demonstrated ability to lead product verification & validation activities.

What We Offer:

A challenging and rewarding career opportunity in a dynamic and innovative environment.

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