Quality Validation Engineer

3 weeks ago

Longford, Ireland Cpl Full time

Quality Validation Engineer - Medical Device, Longford

Client: Cpl

Location: Longford, Ireland

Job Category: Other

EU work permit required: Yes

Job Reference: 4db567a7db98

Job Views: 5

Posted: 01.06.2025

Expiry Date: 16.07.2025

Job Description:

We are seeking an Experienced Validation Quality Engineer for a medical device manufacturing facility in Longford. The role involves supporting the qualification of new tools and product introductions on-site. This is a permanent position with benefits. Interested candidates should email an updated Word copy of their CV.

Responsibilities:
  • Write and execute process validation protocols and reports for new product introductions and revalidations, utilizing scientific and technical knowledge.
  • Develop and implement solutions to sustain and improve the QMS.
  • Maintain compliance with ISO standards.
  • Participate in site change control processes, ensuring effective implementation of validated process changes.
  • Generate risk assessments related to cleaning, validation, and processes.
  • Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
  • Support GMP and regulatory audits.
  • Prepare and deliver training modules as needed.
  • Perform data analysis and make informed decisions based on data.
  • Support continuous improvement initiatives using Lean Six Sigma methodologies.
  • Execute and develop change controls.
  • Perform root cause analysis of system failures using tools like FMEA, Fishbone diagrams, and 5 Whys.
  • Implement corrective actions through change management systems.
  • Lead cross-functional teams and liaise with vendors on projects.
Requirements:
  • Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience.
  • Experience in statistical analysis (Minitab), SPC, and validations.
  • Excellent interpersonal, communication, influencing, and facilitation skills.
  • Experience as a Validation Engineer in an injection moulding or medical manufacturing environment.
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