Job Reference: JO-2009-65388_1600255776
Our Limerick based Medical Device client is looking for an experienced Quality Engineer in relation to a contract Staff QE role.
Business Unit Support
- Business Unit Non-Conformance (NC), CAPA, Complaints and Validations management − This includes investigations related to NC's and complaints, trending of same and assessing need for CAPA.
- Responsible for investigation/disposition of on hold product and material (including supplier related holds) up to and including escalation to MRB − Support both Internal and external audits, act as Business Unit Subject Matter Expert Business Improvements − Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
- Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
- Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
- Product Quality, Control & Disposition and Performance Standards − Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
- Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality Product/Process Qualification − Approve IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans − Partners with Global Supply chain, Finished Goods and material suppliers to ensure appropriateapplication of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
- Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
- Partake in Change Request (CR) management for the Business Unit enduring appropriate and timely review and approval of CR's in partnership with Business Unit peers.
- Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs − Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements Strategic − Conduct strategic planning with business unit leaders.
- Partnership with other functions to establish business priorities and resource allocation − Ensures effective quality strategies are created for the validation of test methods, process and design.
- A minimum of a Bachelors Degree, preferably in Engineering or related technical field.
- Requires 5-8 years related experience.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Experience with a proven track record of implementing appropriate risk mitigation.
- Experience working in both an FDA and European regulatory environment is preferred.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
- The ability to perform "hands on" troubleshooting and problem solving is required. The ability to think on the feet and providing sound judgment is highly desired.
- Good technical understanding of manufacturing equipment and processes is required.
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