A Quality Compliance Engineer is required by a leading Medical Device Contract Manufacturer based in Cork. The Cork facility is a global strategic expert in the automated production of medium-high volume complex and disposable medical devices. The facility has been in operation for over 30 years. This is an opportunity to work in an ever changing and technologically advanced site.
Excellent opportunity for a Quality Engineer to work as part of a Quality team with responsibility to identify, define & implement key processes and system improvements such that they are closed loop.
In this role the Quality Compliance Engineer will be responsible for:
o Process mapping, procedural review and development, work instructions review and deployment site wide.
o Support QMS integration activity across the site
o Participate in local change and CAPA boards
o Ensure timeliness of ECR’s/SCN’s/CAR’s/PAR’s/SCAR’s,Customer SCAR’s,
o Conducting Audits to ensure conformance and effectiveness of the Quality System.
o Data and trend analysis and reporting.
The Quality Compliance Specialist requires:
o 5 – 10 years experience in Medical / Regulated Industry.
o 5 – 10 years Technical Functional / Manufacturing experience (i.e. Eng, QA, Validation, Standards and Systems)
o Experience in working within a Class 3 Medical Device Manufacturing Environment.
o Six Sigma Green or Black Belt Certified.
o Experience in New Product Introduction Processes.
If this role is of interest, please call Regina at LSC on 021 4777 329 or apply directly through this advert.