​What you need to know

Our client, a reputable and globally renowned medical devices company based in Co. Westmeath is currently seeking a Quality Engineer to join its Quality team.

As a Quality Engineer, you will report to the Quality Manager on-site and work with your colleagues to perform defined quality activities that will lead to the development and implementation of new or improved processes and systems.

This position is a 6-month contract.

Your new job

Key duties & responsibilities include:

• Initiating and completing technical activities and cost savings as part of process improvements

• Updating of risk documentation, procedural updates, test methods, process/software validation etc., that have a significant impact on the business.

• Initiating, reviewing, and approving change controls.

• Performing, analysing and interpreting statistical data using statistical tools and methods.

• Developing a strategy and implementing appropriate sampling methods

• Write up and review of CAPAs, NC/NCMRs and SCARs to address compliance issues and providing guidance to suppliers and engineering.

• Ensuring compliance is maintained for Product Manufacturing, Packaging and Labelling.

• Performing Internal and Supplier Audits.

• Supporting and participating in external regulatory body audits, e.g., ISO and FDA

• Creating and analyzing data for Quality Metrics.

• Complying with all relevant training required and adhering to relevant associated documentation.

• Abiding by Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.

• Following strict adherence to the requirements of CGMP.

• Actively contributing to the enhancement of compliance initiatives for areas of responsibility.

What are we looking for?

• Degree in Engineering, Science or another related field.

• Three (3) years experience working in a regulated environment, specifically medical device, FDA or ISO 13485 registered work environments is preferable.

• Strong IT skills (MS Excel, PowerPoint, Word etc.)

• Strong knowledge of statistical analysis tools such as Pareto charts and trend charts.

• Excellent knowledge and ability to use FMEAs (Failure Mode and Effects Analysis) and other root cause analysis tools.

• Experience with using problem-solving techniques.

• Ability to effectively communicate technical information, both verbally and in writing, to both non-technical and technical associates.

Apply for this job now with a Word version of your CV or get in touch with Oliver at oliver@matrixrecruitment.ie

By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and permission. Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position.

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