Senior Quality Assurance Specialist

6 days ago


County Dublin, Ireland Life Science Recruitment Ltd Full time

Job Overview

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Focused on driving the day-to-day implementation of the Quality Management System (QMS) with a strong emphasis on continuous improvement. This role supports manufacturing, supply chain, and design assurance activities while representing the quality function across various teams.

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Main Responsibilities:

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  • Lead QMS implementation and lead continuous improvement activities to ensure delivery of overall quality strategy and support achievement of business quality objectives.">
  • Collaborate with wider teams to ensure necessary QA activities are planned, executed, and documented in accordance with relevant standards.">
  • Develop and review test specifications, part specifications, and design specifications with cross-functional teams.">
  • Support manufacturing team activities associated with regulated environments, including equipment qualification, process validation, and change control.">
  • Provide practical QA and Design Assurance expertise to support supply chain activities such as process development and manufacturing requirements.">
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Requirements:

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Bachelor's Degree in Engineering, Science, or related field with 3+ years' experience in medical device quality/design assurance roles.

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Recent regulatory experience, including FDA regulations, ISO 13485, Medical Device Directive, and other applicable national and international regulations and standards.

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Desirable: Master's degree in Engineering, Science, or related field; experience in implantable medical devices; process development and change management in regulated environments.

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Benefits:

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A dynamic work environment with opportunities for growth and professional development.

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