Design Assurance Engineer

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What you need to know

One of my key clients I work with in the Medical Device industry is on the look out for a Design Assurance Engineer. Located near the border Co Galway, it would be a viable commute from various locations in the Midlands and West.

This is a permanent job with a company that has excellent benefits, operates under a flat hierarchy, has a culture conducive to growth and collaboration – and they work a four-day week. So, if it’s a better work/life balance and job satisfaction you’re looking for, then this is the opportunity you’ve been waiting for…..

Your new job

The Design Assurance (DA) Engineer is a key member of the Quality team charged with establishing, implementing and maintaining the Quality Systems on site. As part of the Projects team, you will participate in new product & technology development, project design plans and process changes.

This is a very collaborative role, where you will liaise a lot with R&D and Process Engineers to ensure that the transition of products through R&D to ensure product approval and manufacturing scale up are delivered in a smooth, timely and cost-effective way.

Key duties & responsibilities:

  • Defines and implements Quality standards and specifications to ensure that Regulatory requirements are met, whilst continually seeking to improve product and process quality
  • Develops and executes required validations in line with regulatory standards to include equipment, process and product validations
  • Conducts root cause analysis and implements corrective action in a timely manner
  • Conducts audits, including closing out audit findings and creating and determining proper corrective and preventative action
  • Liaise with sterilisation and test facility to ensure sterilisation, product testing & micro requirements are achieved and that negative results are investigated

What are we looking for?

  • An Engineering or Quality Assurance Degree or equivalent experience
  • Minimum of 3 years post qualification experience as a Design Assurance Engineer within a Medical Device or regulated environment
  • Strong working knowledge of the product development process in the medical device industry
  • Detailed knowledge of FDA, European & International regulatory requirements
  • Ability to support and lead DA activities on multiple projects simultaneously
  • Strong technical writing and verbal communication skills

Apply for this job now or get in touch with Gareth on 090 6490485.

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Recruitment Consultant: Gareth Morris

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