Quality Engineer

https://www.teamhorizon.ie/job-search/1404-quality-engineer/quality/mayo/job2024-08-22 14:57:102052-01-06Team Horizon
Job TypeContractor
AreaMayo, IrelandRoscommon, IrelandSligo, IrelandLeitrim, IrelandMayoIreland
SectorQuality
Start Date
AdvertiserAshling Guthrie
Job Ref3375
Job Views134
Description

Team Horizon is seeking a Quality Engineer on of our client, a leading medical device manufacturer in the Connaught region.


 


 


 


Why you should apply:



  • Opportunity to work as a member of a diverse Quality Team to ensure that Quality goals and objectives are achieved


 


What you will be doing:



  • Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements.

  • Audit the quality system with other personnel where required.

  • Assist in the investigation and coordination of customer complaints and assess the need for implementation of effective corrective or preventive actions.

  • Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, correction and corrective actions.

  • Measure performance of the Quality System and provide metrics, for inclusion in the management review, monthly reports etc

  • Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.

  • Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary

  • Verification of effectiveness of corrective/preventive actions arising out of product process and quality system non-compliance.

  • Ensure implementation and compliance with relevant Regulator requirements.

  • Assist in the performance of validation activities at the site.

  • Ensure Quality System documentation is thorough, complete, and compliant.

  • Ensure compliance with training requirements is maintained.

  • Review lot records, ensuring documentation is compliant with requirements and completing lot release for shipment.

  • Inspect incoming products and manage the supplier Quality relationship.

  • Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site.

  • Complete in-process and final release product testing per the relevant approved specifications and procedures.

  • Where required. Review batch records, ensuring documentation is compliant with requirements.

  • Complete disposition decision for the batch.

  • Participate in Risk Management activities as required.



 


What you need to apply:



  • Degree in an Engineering, Science, Quality or other discipline

  •  Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable. 

  • 2 years plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment.

  • Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as process validation, design controls, CAPA, auditing, etc., is desirable.


 


 

Apply Later
Sign in
Register
Apply
Later
Ashling Guthrie
Browse Ashling's jobs
Get in touch with Ashling
Similar Jobs
  • Operations Lead
    Ireland, Dublin
    Quality

    Team Horizon is seeking an Operations Lead on behalf of a biopharmaceutical manufacturer in Dublin. In this role you serve as primary production process owner responsible for New Product Introduction, Life Cycle Management Projects and/or CAPEX projects and established process improvements projec...

  • Sterility Assurance Lead
    Ireland, Sligo
    Quality

    Team Horizon is seeking a Sterility Assurance Lead for our Client, a global biopharmaceutical company who are committed to transforming lives & driving innovation.

     

     

    Why you should apply:

    This is an important role, and you will valued part of the quality org...
  • QA Operations Manager
    Ireland, Sligo
    Quality

    transforming lives & driving innovation.

     

     

    Why you should apply:

    This is an excellent opportunity and is a high impact role where you will lead a diverse team of quality professionals that are responsible for quality operations for the site, including batch ...
Email Me Jobs Like This
Subscribed to similar jobs notifications
Name:*
E-mail:
Subject
Phone
Textarea:
We use cookies to provide you with the best possible browsing experience on our website. You can find out more below.
Cookies are small text files that can be used by websites to make a user's experience more efficient. The law states that we can store cookies on your device if they are strictly necessary for the operation of this site. For all other types of cookies we need your permission. This site uses different types of cookies. Some cookies are placed by third party services that appear on our pages.
+Necessary
Necessary cookies help make a website usable by enabling basic functions like page navigation and access to secure areas of the website. The website cannot function properly without these cookies.
ResolutionUsed to ensure the correct version of the site is displayed to your device.
essential
SessionUsed to track your user session on our website.
essential
+Statistics
Statistic cookies help website owners to understand how visitors interact with websites by collecting and reporting information anonymously.
Google AnalyticsGoogle Analytics is an analytics tool to measure website, app, digital and offline data to gain user insights.
Yes
No

More Details