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Senior Quality Assurance Specialist

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Sligo, Sligo, Ireland beBeeValidation Full time €40,000 - €60,000

Quality Assurance Specialist

">

This role involves leading the quality system in a regulated environment. As Quality Assurance Specialist, you will be responsible for ensuring compliance with international standards, such as ISO 13485 and ISO 9001.

">Key Responsibilities:">
  • ">
  • Coordinating the quality system, including design control, validation, and change control programs.">
  • Performing risk assessments and maintaining associated risk documentation.">
  • Assisting in investigations of customer complaints and non-conformances, and implementing corrective/preventive actions.">
  • Reviewing and approving documents generated in the Validation Management System (VMS).">
  • Managing key site projects and liaising with internal and external stakeholders.">
  • Maintaining records of performance metrics and reporting to management.">
  • Ensuring all personnel are aware of quality requirements through training and awareness programs.">
">EHS Responsibilities:">
  • ">
  • Maintaining Environmental Health & Safety standards and adhering to regulations and procedures.">
  • Demonstrating accountability for EHS performance and compliance through active participation in Abbott's EHS Program.">
  • Reporting work-related injuries or illnesses and assisting in investigations.">
">Requirements:">
  • ">
  • Degree or diploma in an engineering, science, or quality-related discipline.">
  • Strong working knowledge of quality systems regulations, including ISO 13485 and ISO 9001.">
  • Proven validation skills in a regulated environment.">
  • Risk management skills, including risk assessment and understanding of ISO 14971.">
  • Project management and organizational skills.">
  • Excellent interpersonal/communication skills.">
  • Ability to integrate into a team environment.">
">Seniority Level:">
  • ">
  • Entry level">
">Employment Type:">
  • ">
  • Full-time">
">Job Function:">
  • ">
  • Quality Assurance">
">Industries:">
  • ">
  • Hospitals and Health Care">