Job title: Quality Engineer
Location: Business Innovation Centre, NUI Galway
Benefits: Excellent salary, pension, healthcare and yearly bonus.
My client have just been acquired by a Medical Device multinational and about to go through a massive growth phase. Amazing opportunity for someone who wants to get into a start-up who are strongly supported and develop their career in a company from the ground up.
The Quality Assurance Engineer is a key member of the Quality team with responsibility for establishing, implementing and maintaining the Quality System on site.
- 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
- Defines and implements Quality standards and specifications and helps to ensure that Regulatory requirements are met. Continually seeks to drive improvements in product and process quality.
- Participates in new product/technology development and supports the QA activities as part of an overall project
- Executes the project design plans, protocols and generates reports for new product development projects as well as design/process
- Develops and executes required validations in line with regulatory standards to include equipment, process and product
- Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related
- Ensures appropriate process monitoring / controls are in place to maintain an effective validated process.
- Conducts root cause analysis and implements corrective action in a timely
- Managing and investigating customer complaints including carrying out failure mode analysis and implementing required CAPAs relating to complaints where required
- Conducts audits, including closing out audit findings and creating and determining proper corrective and preventative
- Partner with suppliers to ensure their quality standards are in line with company
- Maintenance of an effective quality management system in compliance with applicable regulatory requirements, including ISO13485.
- An Engineering, Quality Assurance or equivalent Science Degree (or equivalent experience).
- A minimum of 3 years post qualification experience in a quality function with proven quality assurance experience within a Medical Device or regulated environment.
- Driving licence required to travel between sites in Galway city if required.
Would you be interested in hearing more about this exciting company and the position available?
If so forward an up to date CV or email me and we can organise a time to have a call and discuss further.
Look forward to hearing from you,
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales