Connecting...

Quality Engineer

  • Location:

    Cork

  • Contact email:

    barbara@sigmar.ie

  • Sector:

    Engineering

  • Contact phone:

    +35314744600

  • Job type:

    Full Time

  • Job ref:

    BSz201221HCLQE

  • Salary:

    €50,000 - 70,000

  • Published:

    29 days ago

  • Contact email:

    barbara@sigmar.ie

Job description

About Your New Employer

This is an exciting opportunity for a motivated Quality Engineer with experience in the project space to join an industry leader and progress their career. 

This is a place where you can find a career with a meaningful purpose, work on interesting multinational projects, and have a significant impact on shaping the future of the healthcare technology sector.

About Your New Job

  • As a Quality Engineer, you will represent Quality as part of a cross-functional team to ensure delivery of projects (NPI’s and Technology) into production with the highest level of quality, compliance, and adherence to timelines.
  • You will compile and execute validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.
  • You will use of statistical analysis as part of validation activity and defining subsequent inspection, and controls in production.
  • Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
  • Liase with R & D to ensure Critical to Quality Characteristics are agreed and documented for all New Product Development.
  • In this job, you will lead Design for Inspection activities for all New Product Introduction to ensure the latest technology is available to reduce Human Error.
  • You will lead QA input to Design for Manufacture activities on site.
  • You will ensure daily and project compliance with all Documented Quality systems i.e. FDA QSR’s and ISO 13485/9001 requirements etc. during all day to day.
  • You will provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.

What Skills You Need

  • A degree level or similar qualification in mechanical or industrial engineering
  • Minimum 2 years experience in a quality role within a regulated industry
  • Process validation
  • Experience in equipment measurement and risk management
  • General knowledge of quality disciplines 
  • Proven ability to successfully introduce new product development in the Medical Device Industry
  • Proven knowledge and ability regarding product verification and process validations
  • Proven knowledge of FDA and MDD GMP requirements regarding Medical Devices

What’s on Offer

This is a permanent role with a competitive salary, and good benefits package!

What’s Next​

  • Apply now by clicking the “Apply Now" button or call me, Barbara Szatkowska on +353 86 796 1534 or if the job isn’t quite right but you are looking for something similar, please get in touch!

Why Apply Through Sigmar?

  • We’ll help manage your job hunt, strengthen your interview skills and tidy up your CV
  • We’ll provide you with an overview of the jobs market within your industry and help you tailor your jobs search
  • Gain access to exclusive roles that are not advertised elsewhere

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.