Quality Assurance Technician

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What you need to know

You will work as the Quality Assurance Technician for our client, a highly successful and established medical device company in Co. Galway.

You will be responsible for performing a variety of Quality and support roles in the production/manufacturing department. You will be a key member of the Quality team charged with establishing, implementing and maintaining the Quality System on-site. You will work within the Quality Department reporting to the Quality Assurance Engineer.

This is a permanent role.

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Key duties & responsibilities:

  • Ensure all processes & equipment are setup per procedure and ready for production.
  • Monitor production yields and support yield improvement activities.
  • Provide ongoing day to day support to Production; continually seek to drive improvement in operation performance while also maintaining the highest levels of regulatory conformance.
  • Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, Bills of Materials, Product routings, Manufacturing procedures, and Logs and ensure that these documents are adhered to at all times.
  • Provide Quality support to process validation activities.
  • Work as a member of the core team (Supervisor, Training, and Quality) to manage daily line performance, practice versus procedure adherence.
  • Liaise with engineers and suppliers to ensure all latest versions of documents are released and available at point of use locations.
  • Gather and compile the quality operational monthly Key Performance Indicators reports across the Quality Management system.
  • Carry out investigations and generate reports as required to correct non-conformances and implement effective corrective actions.
  • Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related findings.
  • Partner with R&D and Process Engineers to ensure that the transition of products through R&D, product approval and manufacturing scale-up are smooth, timely and cost-effective.
  • Conducts root cause analysis and implements corrective action promptly.
  • Creates and maintains company quality documentation.

 

What are we looking for?

  • Quality qualification.
  • At least 2 years’ experience in a Medical device environment or similar industry.
  • An analytical approach to problem-solving.
  • A self-starter that applies their initiative in most situations.
  • Team player, ability to work on cross-functional teams.
  • Strong communication skills.
  • Capacity to make sound judgments while learning from mistakes.
  • Excellent attention to detail.
  • Strong interpersonal skills, a demonstrated ability to influence his/her peers and place quality at the forefront of everyone’s daily agenda.
  • Displays the highest levels of integrity.
  • Capacity to maintain the highest levels of confidentiality internally and externally.
  • Ability to stay connected to multiple projects simultaneously.

 

Apply for this job now or get in touch with Áine on 090 64 90485.

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Recruitment Consultant: Áine Clehane

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