Quality Engineer

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  • Job type:

    Full Time

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  • Salary:

    €50,000 - 70,000

  • Published:

    29 days ago

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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!

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