Product Quality Assurance Professional

2 weeks ago

Dublin, Dublin City, Ireland beBee Careers Full time

Quality Assurance Expert

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Are you a detail-oriented professional with a passion for ensuring quality in products? Do you have experience in regulated environments and a strong understanding of FDA regulations?

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We are seeking a Quality Assurance Expert to join our team. As a key member of our quality assurance department, you will be responsible for contributing to and leading various activities, including process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing process deviations, non-conformance handling, and validation.

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Your tasks will include:

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  • Contributing to and leading a broad range of activities, including process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing process deviations, non-conformance handling, and validation.">
  • Active participation in change management via verification and validation of product, process change, technology transfer plans, equipment commissioning, deviations, non-conforming material, out of tolerances, complaints, continuous improvement changes, and post-production surveillance.">
  • Serving as a key liaison and knowledge transfer champion among Quality Assurance, Manufacturing Engineering, R&D, Production, and Documentation Control.">
  • Focusing on and being responsible for process quality design improvements and updating quality system procedures to achieve fully compliant and lean processes.">
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To be successful in this role, you will need:

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  • 5 years' relevant experience in a regulated environment with a strong understanding of FDA regulations and risk management.">
  • Minimum of a third-level qualification (Diploma/Degree) in an appropriate discipline (Quality Management, Mechatronics, Electronics, or Mechanical Engineering) OR commensurate experience.">
  • Experience in being part of teams and projects with strong communications written and verbal skills.">
  • Ability to work in technically complex multi-discipline areas across the whole supply chain, including the supplier environment.">
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You will possess:

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  • High-paced individual with a bias for action, able to follow assignments through to completion.">
  • Cross-technology and cross-discipline collaboration skills, with aptitude for systems-level thinking and development of standard operating procedures.">
  • Strong communication and presentation skills, with ability to present complex messages concisely.">
  • Familiarity with statistical analysis and design of experiment experience, as well as computer literacy and interface to Product Lifecycle tools such as SAP, Teamcenter, or other.">
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As a member of our global team, you will be part of over 70,000 highly dedicated employees across more than 70 countries, passionate about pushing the boundaries of what's possible in healthcare. We aspire to create better outcomes and experiences for patients worldwide, and our portfolio is crucial for clinical decision-making and treatment pathways.

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We are committed to inclusivity, where every individual's power and potential can be unleashed. Our culture sparks ideas that lead to positive impact and continued success.

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Please create a profile in our talent community to upload your CV and showcase your interest in career opportunities with us.

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