Senior Quality Engineer

3 weeks ago

Limerick, Ireland Life Science Recruitment Full time

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties
  1. Business Unit Non-Conformance (NC), CAPA, Complaints and Validations management
  2. This includes investigations related to NC’s and complaints, trending of same and assessing need for CAPA.
  3. Responsible for investigation/disposition of on hold product and material (including supplier related holds) up to and including escalation to MRB
  4. Support both Internal and external audits, act as Business Unit Subject Matter Expert
  5. Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
  6. Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
  7. Review/analyse whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
  8. Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
  9. Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
  10. Conduct investigation, bounding, documentation, review, and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
  11. Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
  12. Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
  13. Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
  14. Approve IQ, OQ, PQ, TMV or Software Validation

Education & Experience
  1. A minimum of a Bachelors Degree, preferably in Engineering or related technical field.
  2. Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
  3. Experience with a proven track record of implementing appropriate risk mitigation.
  4. Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
  5. A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
  6. Demonstrated project management and project leadership abilities are required.

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.

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