An exciting opportunity for a Quality Engineer to join our client, a world-renowned manufacturer of medical devices based in Cork on an initial 18-month contract (great scope for extension/permanency). This role will be based onsite Mon-Fri with standard office working hours. This role would suit someone with a junior-mid level profile of experience, ideally coming from a regulated, manufacturing environment.
Role Responsibilities:
1. Supervision of Quality Technicians.
2. The Quality Engineer will drive and implement process improvements to ensure predictable processes across all product lines (. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
3. The Quality Engineer will provide effective and responsive QA support to Operations to meet their area's objectives of quality, cost and output.
4. The Quality Engineer will ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (. Use of DOE studies, FMEA's).
5. The Quality Engineer will drive and implement plant wide quality system improvements.
6. Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (. FDA and TUV).
7. Provide functional expertise to other support functions on quality related issues (. regulatory requirements, statistical techniques, sampling principles).
8. Identification and implementation of appropriate statistical techniques to monitor process performance (. SPC, CpK analysis, sampling techniques).
9. Approval of change requests for product, process and quality system changes.
10. Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
11. Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
12. Compilation of required Regulatory documentation (cal files, Design Dossiers, Product transfer files, Essential requirements).
13. The Quality Engineer will perform internal quality audits.
Role Requirements:
14. Minimum of Bachelor of Science Degree in Engineering/Technology.
15. 2/3 years' experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
16. Experience in the medical device industry is an advantage.
17. Experience on an automated/high volume line an advantage.