Senior Design Quality Assurance Specialist

7 days ago


Galway City, Ireland Johnson & Johnson Full time

About the Role

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This position is responsible for providing technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products, and modifying existing designs.

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Key Responsibilities Include:

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  • Assure compliance to applicable regulations and lead quality activities such as risk assessments, device testing, audits, procedure development, documentation review, and changes to controlled documents.">
  • Provide design control, risk management, and compliance support for product design and manufacturing, corrective and preventive actions, product/process improvements, and complaint investigations.">
  • Responsible for ensuring Cerenovus Design Control and Risk Management activities comply with requirements of the Cerenovus Design Control and Risk Management processes.">
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Requirements

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The successful candidate will have a degree in a technical field and at least 5 years' experience in the medical device industry or IVD/pharmaceutical sector.

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Demonstrated knowledge of design control, sterilization, and Quality Assurance processes is essential.

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A working knowledge of 21 CFR 820, ISO13485, and other foreign medical device quality system requirements is also required.

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Ability to handle multiple projects simultaneously, discern major quality issues, and work well under deadlines and pressure are essential skills.



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