Medical Devices JobsQuality Engineer

  • 50942
  • Permanent
  • Offaly, Westmeath

Collins McNicholas

Quality Engineer

Responsibilities:

  • 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
  • Detailed Review and approval of Risk Managements files
  • Review and Approval of Change Orders associated with components and manufacturing process,
  • Provide Operational QA Support for products and process.
  • Lead / team member of CAPA as required
  • Oversight and management of the MRB process
  • Lead KATA investigations towards root cause

Qualifications:

  • Education:

Bachelor’s degree in Engineering (Biomedical, Mechanical, or Electrical) .

  • Experience:
    • 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.

          For more information or a confidential discussion on the role, please contact David Lennon

          Tel: 0906478104

          Email: David.lennon@collinsmcnicholas.ie

          First Name

          Surname

          Your Email (required)

          Your mobile (required)

          Where did you first find out about this job?

          Comment / Cover Letter

          Upload CV

          In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

          We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

          Related Articles

          Lean into fear! What are you afraid of?

          Nicola Wash Galway Blog
          We all see the motivational messages on social media – “be your best self”, “lean into fear”, “push yourself outside of your comfort zone” – and for a brief minute we vow to. But something stops us – fear. There’s the fear of going for it – of making a change. Fear of failure, of […]
          Read More
          • Find a job
          • Apply
          • Get a job