Quality Management System Specialist

2 weeks ago

Galway, Ireland Abbott Laboratories Full time

About Abbott

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

This is how you can make a difference at Abbott:

The Quality Management System Specialist is responsible for helping our Global business function by supporting the delivery and maintenance of solutions in the complaint handling and post-market surveillance space, primarily the Abbott Quality Complaint Handling process and IT system.

Main Responsibilities:

  • Support users to ensure the smooth day-to-day operation of the Helix Complaint Management System.

  • Maintain key system master data to ensure the system can correctly process all tickets.

  • Review, disposition and action requests from users for system support in conjunction with the IT Run Support team.

  • Identify business needs and recommend viable solutions to meet those needs while ensuring regulatory compliance and supporting strategic decision-making.

  • Collate and curate requests for future system enhancements. Conduct regular reviews with Business Unit Stakeholders to correctly prioritise requests for inclusion in future releases.

  • Partner with IT to deliver solutions on time and on budget.

  • Analyse the results of solution implementation to determine effectiveness and capture lessons learned.

  • Liaise between internal customers and IT during preliminary installation and testing of new features and system functionality.

  • Act as key system Subject Matter Expert for designing and providing user training.

  • Maintain procedures, work instructions, and job aides to align with system changes and user needs.

Experience and Skills required:

  • Level 8 or higher qualification in Science, Engineering or IT discipline.

  • 5 years + experience in a regulated industry with GxP complaint systems, experience with Trackwise Digital an advantage.

  • Experience working within a Quality Management System to manage compliant business processes.

  • Proven track record in delivering KPIs in a changing environment.

  • Demonstrated written and verbal communication, negotiation and influencing skills.

  • High degree of computer literacy, including a working understanding of cloud-based SaaS solutions.

  • Excellent Project management skills.

  • Interaction with sites in different time zones may occasionally require out-of-hours working.

What we offer:

Attractive compensation package that includes competitive pay, as well as benefits such as:

  • Family health insurance

  • Excellent pension scheme

  • Attractive bonus

  • Life assurance

  • Career Development

  • Growing business plus access to many more benefits

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