One of my key clients in Cork are currently seeking an experienced NPI Quality Engineer to join their innovative NPI team on a 12 month hourly rate contract. The company are a global medical device company, and specialise in the manufacture of cardiovascular products including catheters and inflation devices.
Role: NPI Quality Engineer
Contract: An initial 12 month hourly rate contract
Your role as an NPI Quality Engineer will be to act as a member of the Quality Team onsite. You will provide expert QA support to the NPI teams on site, and ensuring new products are launched in a timely manner.
- Drive risk reduction and eliminate risks and error proofing through continuous improvement.
- Ensure that all new product Quality Continuous Improvement ideas are completed in a timely manner.
- Ensure all process changes and improvements are risk assessed.
- Ensure all process variables and their interactions are adequately defined.
- Ensure all non - conformance's and CAPA's are completed in a timely manner.
- Ensure compliance at all stages of Product Lifecycle Development Process on site.
- Support the internal audit program.
- Review of change notices for product, process and system changes, and validation builds.
- Ensure regulatory compliance in are of responsibility to cGMPs of all medical device regulatory agencies.
- Provide functional expertise to cross functional teams including R&D, Regulatory and Manufacturing teams.
- 5+ years' experience within Quality / Validation roles within a medical device company.
- Degree in Science / Engineering disciplines.
- Risk management experience.
- Proven ability to work as an individual or as part of a team.
- Previous experience working with cardiac devices is desirable.
No CV ready? Not sure yet? Feel free to contact me for further details.
This is an excellent opportunity for an experienced Quality Engineer to join a global leader within the medical device industry, and work alongside innovative and experienced Quality Engineers.
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 Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales