Chief Design Assurance Officer

7 days ago

Galway, Galway, Ireland beBeeDesignAssuranceEngineer Full time €60,000 - €92,000
Design Assurance Engineer Role">

Job Summary

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This is a challenging and rewarding role that requires the right candidate to lead the design assurance function for commercially released medical device products.

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The successful candidate will play a key role in supporting the lifecycle of these products, ensuring continued compliance with risk management and design control requirements.

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They will also be responsible for managing design changes, executing product / material design changes, providing DA technical direction / input to process changes, understanding risk management concepts, maintaining and updating the risk management file, generating Design Verification (DV) plans, protocols & reports, and execution of DV testing.

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In addition, they will ensure continued design control compliance, including design history file (DHF) maintenance, verification/validation planning, and traceability. They will also support complaint handling by participating in technical investigations, root cause analysis, and determining appropriate corrective and preventive actions (CAPA).

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The ideal candidate will have a strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, and relevant guidance documents. They will also have experience with design control and risk management throughout the product lifecycle, including relevant experience in some or all of the following: design verification execution, biocompatibility, human factors and usability, statistical analysis, sterilisation.

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They will also have established and productive individual contributor who works independently with general supervision on larger, moderately complex projects and assignments.

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Requirements

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  • ">
  • A minimum Bachelor's degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Science).">
  • Minimum 2-3 years of experience in design assurance, quality engineering, or product development in the medical device industry.">
  • Strong analytical, communication, and documentation skills.">
  • Detail-oriented with the ability to manage multiple tasks in a fast-paced environment.">
  • Dynamic team player who can work effectively and proactively on cross-functional teams.">
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Benefits

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As a key member of our organization, you will have the opportunity to grow professionally and contribute to the success of our company.

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You will also have access to ongoing training and development opportunities to help you advance your career.

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Other Information

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Interested candidates should have excellent problem-solving skills and be able to adapt to changing priorities.

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They must also be highly organized and able to prioritize multiple tasks simultaneously.

">Keywords: DesignAssuranceEngineer

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