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Senior Quality Engineer

Posted on Mar 10, 2020 by Real Staffing Group

Galway, Ireland
Engineering
Immediate Start
Annual Salary
Full-Time

Job Title: Senior Quality Engineer

Location: Parkmore, Galway.

Benefits: Excellent career progression, salary, pension, healthcare and a yearly bonus.

Company:

My client in the Medical industry are experts in medical device prototyping and 3D printing. They work with companies of all sizes, delivering rapid 3D prototyping services for early stage product design purposes.

Responsibilities:

  • Quality support to assigned product development teams ensuring product manufactured conforms to quality standards, specifications, customer expectations, and associated regulations, eg FDA, ISO and MDD
  • Provision of functional input into risk management processes such as FMEA development, etc
  • Development of risk-based product/process validation protocols for existing and new products/processes
  • Assistance with site to site manufacturing transfers
  • Review and verification of quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areas
  • Provides guidance on equipment calibration procedures as relevant
  • Provides guidance on inspection & test methods and associated sampling plans, etc
  • Performs analysis of inspection data and associated implementation of ship-to-stock program on relevant incoming components
  • Non-conforming product review and disposition, associated investigation and root cause analysis, and implementation of appropriate and effective corrective actions
  • Initiation, review and approval of document change controls
  • CAPA Management
  • Performance of internal audits of the QMS. Provide guidance and support on audit outcomes as relevant

Qualifications:

  • Bachelor's degree in science-related discipline or equivalent
  • 5+ years relevant experience working in medical device-related quality function
  • QMS Auditor Certification desirable

Proficient in:

  • Product and Process Validation, including FMEA, DOE, Test Method Validation, sampling plan analysis, etc
  • Risk Management for Medical Devices and associated tools
  • Six Sigma Problem-Solving Methodologies
  • Change Control
  • Non-Conformance Reporting
  • CAPA Management
  • Technical Writing
  • Presentation Skills
  • MS Office Applications

If you are interested in applying or hearing more about this position forward your CV to the link provided or give me a call to discuss further.

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

Reference: 859593975

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