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Senior Quality Engineer

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 18899

My client based, A New Medical Device Company based here in Galway city are looking to hire a Senior Quality Engineer.

This is a permanent role offering a range of benefits.


The Role:

Provide Quality support for daily operational activities with particular emphasis on Manufacturing Process Support, CAPA, Problem Solving, Lean Six Sigma activities, Rework activities, Risk Management, Supplier Management, Auditing, Non-conforming materials disposition, Calibration, Incoming Inspections, In-Process Inspections, Process Validation, and Packaging/Labelling.


Responsibilities: 

  • Provide Quality support at daily production meetings and weekly Production Planning meetings.
  • Perform regular audits including 5S on production processes.
  • Raise and participate in corrective actions where a non-conformance has been identified at incoming inspection and in-process manufacturing. Utilize appropriate root cause analysis tools and techniques.
  • Initiate / Approve Manufacturing Rework Instructions
  • Participate / Lead Risk Analysis initiatives e.g., FMEA
  • Support the creation of work instructions, visual standards and test instructions relating to manufacturing.
  • Initiate/review/approve Document Change Notifications (DCN’s) associated with manufacturing.
  • Provides Quality support for the transfer of new product into commercialization.
  • Supports validation activities including MVP’s, TMV’s, OQ/PQ, PPQ, and revalidation assessments.
  • Perform statistical analysis using Minitab.
  • Develop and implement cost/value Improvement Projects, utilizing lean six sigma tools and techniques.
  • Support requalification and validation activities associated with Sterilization.
  • Support First Article Inspection (FAI) activities.
  • Supports the vendor change notifications (VCN’s) process.
  • Provision of Operations metrics for Management Review.
  • Represent Quality at both internal and external audits and lead preparation activities in advance of such audits.
  • Support the development, writing and compiling of the Design History Files, Technical Files, Design Dossiers; PMA and 510k submissions for Notified Bodies, FDA, and Competent Authorities where necessary.

Requirements:

  • Degree qualified in related technical discipline or specific recognized qualifications in a quality-related discipline.
  • Minimum 5 years experience in an operations role within the Medical Device or Pharmaceutical Industry
  • Experience and understanding of regulations related to medical devices e.g. ISO 13485, MDD, MDR, and applicable FDA Requirements.
  • Experience in writing documentation in a regulated environment.
  • Experience in conducting audits in a regulated environment.
  • Self-motivated.
  • Effective information gathering.
  • Ability to prioritize tasks.
  • Excellent verbal and written communication skills.
  • Excellent technical writing skills.
  • Proficient in the use of desktop software e.g. excel, word.
  • Desirable to have experience in using statistical software or utilizing statistical techniques.

For more information or a confidential discussion about this role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706 717