Chief Design Assurance Specialist

7 days ago

Galway, Galway, Ireland beBeeDesignAssurance Full time €80,000 - €120,000
Job Title: Design Assurance Program Manager

The primary function of this role is to lead and direct the development and implementation of design assurance strategies across various projects.

  • Key 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.
  • Interact with customer and supplier companies in a professional manner; proactively communicate to ensure an ongoing two-way exchange of information.
  • Auditing and qualification of new suppliers may be required.
  • 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.
Qualifications and Skills:
  • Education: Bachelor's degree in a related field.
  • Experience: Minimum 5 years of experience in a similar role.
  • Skills: Strong leadership skills, excellent communication skills, ability to work in a team environment, strong analytical skills, attention to detail, and ability to meet deadlines.
Benefits:
  • Opportunities for growth and development: Opportunities for advancement within the company.
  • Competitive salary and benefits package: A competitive salary and comprehensive benefits package.
  • Collaborative work environment: A collaborative work environment with a diverse group of professionals.
About Us:

We are a leading manufacturer of medical devices. Our goal is to provide high-quality products that meet the needs of our customers.

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