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Manufacturing Quality Specialist

2 weeks ago

Longford, Ireland Cpl Healthcare Full time

Cpl Healthcare seeks a skilled Manufacturing Quality Specialist to support the successful qualification of new tools / product introduction on-site. The ideal candidate will have experience in statistical analysis, SPC, and validations.

The role involves:

  • Writing and executing process validation protocols and reports for new product introductions and revalidations due to process/material improvements utilizing scientific/technical knowledge.
  • Developing and implementing solutions to sustain and improve the QMS.
  • Maintaining and supporting compliance to ISO 13485 and ISO 14001 systems standards.
  • Participating in site change control, ensuring that all changes to validated processes are effectively identified and implemented.

The successful candidate will have a third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience, excellent interpersonal, communication, influencing, and facilitation skills, and experience as a Validation Engineer within an Injection moulding or medical manufacturing environment.