Senior Design Assurance Specialist

4 days ago

Galway, Galway, Ireland beBeeQuality Full time €80,000 - €110,000
Job Title

Design Assurance Program Manager


Responsibilities
  • Lead Quality Representative on projects, contributing and/or providing guidance to establish appropriate Design History File / Device Master Record documentation.
  • Ensure project teams utilize 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 actions, change control, internal 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 opportunities.

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

The ideal candidate will have a strong background in Quality Assurance, excellent communication skills, and the ability to work effectively in a fast-paced environment. They will be responsible for ensuring that all products meet the highest quality standards and that all processes are compliant with regulatory requirements.

In this role, you will have the opportunity to work closely with cross-functional teams, including engineering, manufacturing, and quality. You will also have the chance to develop and implement new processes and procedures to improve efficiency and reduce costs.

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