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 informationplease contact Cliona O?Malley on 091730022 / email@example.com
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