Design Assurance Engineer
We are currently working with a world-renowned medical device company based in Galway who have an excellent opportunity for a design assurance engineer. The successful candidate will be required to fulfil the assurance responsibilities for product development.
- Summarise, analyse, draw conclusions and makes appropriate decisions from test results or other process related findings.
- The responsibility and authority to make decisions related to product quality, including disposing non-conforming products.
- Interacting with customers on a regular basis; dealing with any queries that they may have regarding products.
- Drive improvements in product and process quality.
- Knowledgeable of QSR and ISO/MDD standards.
- Familiar with validation techniques and associated regulatory requirements.
- Evaluate new equipment/processes for environmental impact to eliminate or lessen such effects.
- Analyse operational, test and validation data to establish technical specifications.
- Analyse performance standards for newly designed or modified products and processes.
- May be required to participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements.
- Use knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
- Provide guidance to Associate Quality Engineer, Technician and Inspection staff.
- Deal with suppliers, other engineering disciplines within and outside of the site as well as customers should the need arise.
Qualifications and Experience:
- Level 8 qualification in a relevant area
- 3 years relevant experience within the Medical Device Industry.
- Good technical capabilities, communication skills, teamwork abilities and initiative.
- Proven ability to work well both as part of a team but also able to work on own with minimum supervision.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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