Quality Assurance Specialist

4 days ago

Athlone, County Westmeath, Ireland beBeeQuality Full time €60,000 - €80,000

Quality Assurance Specialist Role

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We're seeking a skilled Quality Assurance Specialist to join our team. In this critical role, you'll be responsible for initiating and completing technical activities that drive process improvements through the update of risk documentation, procedural updates, test methods, and software validation.

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Your Key Responsibilities will include:

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  • Initiating and reviewing change controls, ensuring compliance with regulatory requirements;">
  • Performing statistical data analysis using statistical tools and methods;">
  • Developing strategies and implementing appropriate sampling methods;">
  • Writing up and reviewing CAPAs, NC/NCMRs, and SCARs to address compliance issues;">
  • Ensuring product manufacturing, packaging, and labeling compliance;">
  • Performing internal and supplier audits;">
  • Supporting external regulatory body audits, such as ISO and FDA;">
  • Creating and analyzing quality metrics data;">
  • Complying with relevant training and adhering to associated documentation;">
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Requirements and Qualifications

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To excel in this role, you'll need:

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  • Education: Degree in Engineering or Science-related field;">
  • Experience: Three years' experience working in regulated environments, specifically medical device, FDA, or ISO 13485 registered work environments;">
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Preferred Skills

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In addition to the above, we prefer candidates with strong computer skills, familiarity with statistical tools like Pareto charts and trend charts, FMEA's, root cause analysis tools, problem-solving techniques, and effective communication skills.

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Why This Role Matters

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In this role, you'll have the opportunity to collaborate with diverse teams worldwide, driving game-changing innovations at the intersection of health, material, and data science.

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The Impact You'll Make

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As a Quality Assurance Specialist, your contributions will directly impact patient lives, enabling healthcare professionals to perform at their best.

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What We Offer

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While we can't share specific compensation details, rest assured that we provide competitive rewards and benefits packages to support your success.

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