Quality Assurance Specialist

2 weeks ago

Cork, Cork, Ireland beBeeQuality Full time €45,000 - €70,000

Job Title: Quality Engineer

Position Overview

This role involves providing quality engineering support and direction in quality assurance, control, and preventative activities within operations and other business functions. Key focus areas include preventative measures and continuous improvement of products and processes.

Key Responsibilities:
  • Work closely with operations and business functions to ensure quality performance of products and processes.
  • Oversight and approval of NC & CAPA, activist and mentor in problem-solving and root-causing activities.
  • Lead and participate in the development and improvement of manufacturing processes for existing and new products.
  • Analysis and review of concession requests.
  • Review and approval of change management activities.
  • Maintain KPIs for monitoring process quality, perform analysis, and interpret trends, taking action as necessary.
  • Support execution and analysis of QATs.
  • Advocate for Human Factor practices, proficient in the science of Human Factor identification and mitigation.
  • Proficient in risk management practices and tools, having high expertise in process risk.
  • Develop and provide input for risk management by identifying opportunities and weaknesses.
  • Proficiency in inspection methods and sampling, supporting First Article Inspections.
  • Proficiency in statistical methods and application.
  • Participate and interface in internal and external audits with regulatory representatives, providing effective narrative and description of topic expertise.
  • Assist in the development, responsible for review and approval of process and equipment validation/qualification.
  • Support manufacturing transfers to other plants/facilities, leading quality activities.
  • Responsible for initiation, management, and support of Ship, Product Holds, potential product escapes.
  • Coach and mentor others in quality topics and activities.
Required Skills and Qualifications:
  • Bachelor's/Level 8 degree in Science or Engineering.
  • 0-2 years similar experience.
  • Keen eye for detail.
  • Strong communication skills.

Location: Cork, Ireland

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