Quality Engineer I

 

Description:


Responsibilities
 

  • Ensure all customer requirements are identified and clearly documented in Freudenberg Medical manufacturing documentation. This documentation includes CHR’s, Work Instructions, Visual Standards, Purchasing Specifications, FMEA’s etc.
  • Document manufacturing procedures, CHR’s, purchasing specifications, visual standards etc. Review and approve all updates to same.
  • Investigate product/process quality issues that arise, including customer complaints. Ensure they are effectively resolved in a timely manner using the Freudenberg Medical CAPA system.
  • Assess all product and manufacturing related changes, deviations and reworks, for their impact on validations, product quality and the customer.
  • Review, control and disposition non-conforming product in accordance with the Freudenberg Medical NCR system.
  • Make product dispositions as and when required. Update documentation such as specifications and visual standards to better define the quality characteristic being dispositioned.
  • Prepare process data such as yield, output rates, No. of NCR’s etc. and use this data to identify opportunities for improvement. Implement improvements on an ongoing basis.
  • Perform internal audits as per agreed schedule and assist with preparations for external audits.
  • Write validation protocols, reports and test reports as required.
  • Perform First Article Inspections as required.
  • Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
  • Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
  • Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc).
  • Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.
  • To take on other duties which the Company may assign you from time to time. These ‘other duties’ will be agreed with Management prior to any assignment.
     

Qualifications
 

  • Degree / Diploma qualification in Engineering, Science and/or Quality or relevant experience in a quality assurance role within the Medical Device Industry.
  • A minimum of 3 years experience in a similar role.
  • Excellent attention to detail.
  • Ability to use problem solving tools (A3, PDCA, 5 Why’s, Fishbone etc.)
  • Good communication skills both verbal and written.
  • A positive attitude in dealing with people.
  • Experience working with Data Analysis Software (i.e. MiniTab) an advantage.
  • Understanding of lean principles. Lean green belt an advantage.
  • Ability to learn and adapt to various situations.

Organization Freudenberg Medical
Industry Engineering
Occupational Category Quality Engineer I
Job Location Galway,Ireland
Shift Type Morning
Job Type Full Time
Gender No Preference
Career Level Experienced Professional
Experience 3 Years
Posted at 2024-07-23 11:53 am
Expires on 2024-12-05