Quality Engineer II
Our client, a leading medical device company based in the Galway, requires an experienced Quality Engineer with minimum two years experience.
Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques)
Approval of change requests for product, process and quality system changes.
Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
Compilation of required Regulatory documentation (e.g. Technical files, Design Dossiers, Product transfer files, Essential requirements).
MRB: Review of MRB trends and identification of appropriate corrective actions when required.
Perform internal quality audits.
Support the implementation of Lean Manufacturing across the site.
Transfer and implement product and processes from development or from another manufacturing facility.
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Education, Experience and Skills;
Ideally will possess Bachelor of Science Degree in Engineering/Technology.
3/4 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated). Experience within a Med Device/Pharma environment i.e. FDA\ISO 9000 necessary.
Excellent interpersonal and communication skills.
Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets.
Experience/training in problem solving and process improvement methodologies. (Engineering Essentials TM).
For further information please contact Cliona O’Malley on 091730022 /email@example.com
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