Quality Lead

Quality Operations Lead

Location: Waterford

My client is seeking an experienced Quality Operations Lead to play a key role in ensuring their quality systems and processes are robust, compliant, and consistently meet both internal and external requirements.

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• Ensure ongoing compliance with applicable standards including ISO 13485, FDA CFR 21 Part 820 (QMSR), and EU MDR.
  
• Maintain audit readiness and lead/support external audits (Notified Bodies, customers, regulatory inspections).
  
• Oversee Quality Operations processes, ensuring alignment with QMS and customer requirements.
  
• Lead and support investigations (e.g. non-conformances, complaints), ensuring timely closure and effective corrective actions.
  
• Manage complaint handling and customer feedback processes.
  
• Maintain and report on Quality metrics.
  
• Drive continuous improvement initiatives across Quality and Compliance.
  
• Support training systems and collaborate with HR on training metrics and reporting.
  

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• Lead, mentor, and develop the Quality team, including Quality Release Inspectors.
  
• Set clear objectives and performance targets aligned with business goals.
  
• Conduct performance reviews, probation reviews, and return-to-work meetings.
  
• Support recruitment and onboarding activities.
  
• Manage team workload, scheduling, and holiday planning.
  
• Promote a positive, high-performance team culture.
  

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• Work closely with Production, Engineering, Leadership, and Regulatory teams.
  
• Support site-wide quality initiatives and ensure alignment across departments.
  
• Act as a key stakeholder in operational and strategic quality decisions.
  

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• Ensure compliance with Health & Safety standards and proactively address risks.
  
• Maintain high standards of housekeeping and operational discipline.
  
• Adhere to and support HR policies and procedures.
  
• Collaborate with other departments and sites as required.
  

3+ years' experience in a quality role within a regulated environment.

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• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820.
  
• Experience in Quality Systems Management. xcfaprz
  
• Proven experience leading and developing teams.