Quality Transformation Specialist

16 hours ago

Athlone, County Westmeath, Ireland beBeeTransformation Full time €55,000 - €85,000

About the Position: We are seeking an experienced Quality Transformation Specialist to lead our client's brand transformation project.

Main Responsibilities:

  • Ensure quality processes, documentation, and systems align with the refreshed identity during a major brand transition.
  • Lead process improvement and cost optimization projects using statistical tools such as DOE, sampling plans, and root cause analysis.
  • Oversight of change controls, risk assessments, and process validations linked to rebrand-driven changes.
  • Management of CAPAs, non-conformances, SCARs, and supplier quality activities to maintain product and process integrity.
  • Internal and supplier audits, and support for ISO/FDA regulatory inspections.
  • Oversee updates to manufacturing, packaging, and labeling processes to reflect the new brand identity while ensuring full compliance.
  • Development and tracking of KPIs to measure quality performance during and after the rebrand.
  • Maintenance of CGMP and EHS standards throughout the transition.

Required Skills and Qualifications:

  • Degree in Engineering, Science, or a related discipline.
  • Minimum 3 years' experience in a regulated manufacturing environment, preferably medical devices or FDA/ISO 13485-certified industries.
  • Strong working knowledge of quality tools (FMEA, DOE, root cause analysis, statistical analysis).
  • Excellent attention to detail with proven problem-solving ability.
  • Strong communication skills, with the ability to explain technical concepts to non-technical audiences.
  • Proficient in MS Office applications (Excel, Word, PowerPoint).

About Total Talent Solutions: Our global leader in the medical device industry is undergoing a brand transformation. We seek individuals passionate about delivering high-quality solutions in a fast-paced environment.

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