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Senior Quality Engineer

Job description

Senior Quality Engineer

About Your New Employer

In your job as Senior Quality Engineer, you will be working for a leading Medical Device company in Galway. In your new job you will be working towards saving people's lives.

About Your New Job

  • You will 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.
  • As Senior Quality Engineer, you are responsible for Generation of Protocols, Reports, Work Instructions, Forms and Procedures. This is to support process development, operational effectiveness, the product realisation process and the QMS.
  • It's your job to liaise with external parties in relation to matters pertaining to the Product Realisation Process execution and QMS effectiveness.
  • You will provide Quality support at daily production meetings and weekly Production Planning meetings.
  • You will be responsible for performing regular audits including 5S on production processes.
  • You will 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.
  • It's your job to initiate / approve Manufacturing Rework Instructions
  • As Senior Quality Engineer you will participate / lead Risk Analysis initiatives e.g., FMEA
  • You will support the creation of work instructions, visual standards and test instructions relating to manufacturing.
  • You will initiate/review/approve Document Change Notifications (DCN’s) associated with manufacturing.
  • It's your job to provide Quality support for the transfer of new product into commercialisation.
  • You will support validation activities including MVP’s, TMV’s, OQ/PQ, PPQ and revalidation assessments.
  • You will perform statistical analysis using Minitab.

What You Need

  • A Bachelor (level 8) of Engineering, Sciences or equivalent experience, minimum of 8 years experience in a healthcare environment.
  • 5 years experience within Medical Device, Pharma industries
  • Experience and understanding of regulations related to medical devices e.g. ISO 13485, MDD, MDR and applicable FDA Requirements
  • Experience in conducting audits in a regulated environment 

What's on Offer

In addition to all statutory entitlements and a meaningful job where you help save lives, you will get:

  • 10% Annual Bonus
  • Fully covered Health Insurance for you and your family
  • Pension Scheme
  • Stock Ownership Programme
  • Flexitime
  • Career Progression Opportunities

What’s Next

Apply for your new job now by clicking the apply button, or contact Dean Flynn at Sigmar Recruitment for more information T: +353 91 455306 E: dflynn@sigmar.ie

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