Medical Device Quality Assurance Specialist

2 weeks ago

Galway, Galway, Ireland beBeeDesign Full time €70,000 - €90,000

**Job Title:** Design Assurance Program Manager

Our company is seeking an experienced professional to lead our quality assurance efforts. As a key member of our team, you will be responsible for ensuring that all products meet the highest standards of quality and safety.

The successful candidate will have a strong background in medical device design and development, with at least 6 years of experience in quality assurance. They will be responsible for leading quality roles on client programs, assisting in the design and implementation of new methodologies, materials, machines, processes, or products.

Responsibilities:

  • Lead Quality Representative on projects, contributing and/or providing guidance to establish 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 Nordson Medical 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.
  • Auditing and qualification of new suppliers may be required.
  • 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 company's Quality Manual.
  • Continually look for improvement and compliance improvement opportunities.

Requirements:

  • Minimum Bachelor's degree in Engineering or related field.
  • 6+ years of medical device design and development/quality assurance experience.
  • 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 is desired.

This role offers a unique opportunity to join a dynamic team and contribute to the success of our organization. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.

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