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Senior Quality Enineer

  • Sector: Medical Devices
  • Contact Email: christopher.otoole@collinsmcnicholas.ie
  • Job Ref: 19213

Our client, an Irish Medical Device start up that is scaling up their operations by introducing a second production line and moving new products into Clinical Trials are looking to add a Senior Quality Engineer to their Quality department. The Senior Quality Engineer will be hired on a permanent basis

This is the perfect opportunity for an experienced Quality professional who wants to be involved in not just the running of systems and production but to be apart of the development of it and overall company growth.



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 Christopher O Toole

christopher.otoole@collinsmcnicholas.ie

091706713