Quality Engineer

3 weeks ago

Limerick, Limerick, Ireland Teleflex Full time

Quality Lead

We are seeking a Quality Lead to oversee all phases of product realization, including NPD, NPI, Commercialization, Sustaining, and End of Life. The role involves ensuring effective implementation of QMS documentation, professional communication with stakeholders, and quality oversight on diverse issues such as complaint and NC investigations.

Key Responsibilities:

  1. Monitor and ensure compliance with GMP and QMS requirements during development and operations.
  2. Troubleshoot quality issues during product development and commercialization, driving solutions to reduce non-conformances.
  3. Provide quality input on validation planning, risk-based decision making, and risk mitigation activities.
  4. Lead vendor and part appraisal processes, process change assessments, and change notifications.
  5. Collaborate with project teams to identify and implement statistical techniques and visual control systems.
  6. Ensure quality plans, test methods, deviations, work instructions, and specifications are in place and followed.
  7. Lead specification reviews and alignments with customer requirements, aiming to reduce process variation.
  8. Oversee product testing, release activities, and disposition of non-conforming materials, including root cause analysis and CAPA.
  9. Establish and monitor process quality performance for continuous improvement.
  10. Respond to customer quality feedback and participate in cross-functional improvement projects.
  11. Develop programs to ensure regulatory compliance and support audits.

Qualifications:

  • Full working knowledge of EN ISO 13485, GMP principles, and FDA QSR 21 CFR Part 820.
  • Degree in engineering, quality, or related discipline.
  • Certified QE preferred.
  • Experience in technical report writing, process validation, FMEA, and protocols.
  • Proficient in statistical analysis and structured problem-solving (Lean Six Sigma Green Belt desirable).
  • Understanding of Lean principles and project management skills.

Additional Skills:

  • Ability to work in a dynamic environment.
  • Understanding of Teleflex ethics standards and processes.
  • Ability to develop technical understanding of products and processes.
  • Strong relationship-building skills with customers and vendors.
  • Effective communication and influence skills.
  • Understanding of manufacturing business drivers.
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