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Quality Assurance Specialist

1 week ago

Galway, Galway, Ireland Life Science Recruitment Full time

About the Role:

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  • This Design Assurance Program Manager position involves leading quality representatives on projects, ensuring the establishment of Design History Files and Device Master Records.">
  • You will be responsible for implementing Nordson Medical Quality Systems across projects, adhering to relevant regulations and industry standards.">
  • Investigating material biocompatibility and sterilization methods is crucial in this role, impacting product design cycles.">
  • Risk assessments of the design will determine its functionality, guiding corrective actions and changes as needed.">
  • Your tasks will encompass CAPA, change control, notifications, audits, product releases, and document control within the design control process.">
  • Professional communication with customers and suppliers is essential, fostering a two-way exchange of information.">
  • The Design Assurance Program Manager must intervene in technical issues and contribute to their resolution.">
  • All work must satisfy the company's Quality Manual requirements.">
  • Improvement and compliance opportunities should be continually pursued.">
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Key Skills and Qualifications:

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  • A minimum Bachelor's degree in Engineering or a related field.">
  • 6+ years of experience in medical device design and development/quality assurance is necessary.">
  • Timely management of customer relationships and responses.">
  • Effective interaction with client companies.">
  • Product verification and validation leadership experience.">
  • Desired: experience developing manufacturing process instructions and operator training.">
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About the Company:

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We specialize in medical device design, development, and manufacturing, offering innovative solutions in complex medical devices and component technologies.

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Benefits:

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  • Contractual hourly rate">
  • Part-time schedule">
  • Hybrid work arrangement">