Quality Engineer required by a Major Medical Devices Company in the Midlands, Ireland
Working in conjunction with Engineering Departments, co-develop design verification & validation protocols for new products (or transfer) and for change on existing products, conduct design verification & validation studies, review and approve protocols, studies, and perform general oversight responsibilities for validation process, for both equipment and processes.
Conduct detailed root cause analysis and define corrective and preventive actions for NCR.
Management of the calibration of QA, Product and Engineering equipment
Work with engineering teams to identify trends in failures, support root cause analysis and implementation of corrective actions
Conduct Internal audits.
Develop Inspection plans for Incoming inspections, in process and Final QA inspection for products manufactured
Education: Bachelor's degree in Engineering (Biomedical, Mechanical,or Electrical) .
Three to five years of experience in a Quality Engineering/Quality Assurance role for medical device or pharmaceutical manufacturing.
Accredited Lead/Biomedical Auditor certification strongly preferred.
Knowledge of IEC 60601 electrical safety standards and RoHS and WEEE regulations strongly preferred.
Lean/Six Sigma certification strongly preferred.
Strong project management skills required.
Demonstrated knowledge of statistical sampling and analysis.
Demonstrated excellent organizational, writing and verbal communication skills
Proficient with the MS Office Suite, including Microsoft Visio and Project.
Experience working in Oracle, Agile and TrackWise systems preferred
Demonstrated knowledge of FDA regulations, applicable medical device/quality system ISO standards, CMDR, MDD and other national and international regulations and standards.
Must be able to work independently with minimal supervision.
Must have the ability to travel, up to a maximum of 25% per month
Salary: A very attractive Salary/Benefits Package is on offer
If interested in applying for this post, please email your CV in Word Format to:
For informal enquiries, please ring Christy on 087-9473404
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