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.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
We Value Your Trust.