Quality Engineer

2 weeks ago

Raynham, United States Cynet Systems Full time

Job Description: Responsibilities: 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. Conduct benchmarking to develop more effective methods for improving quality Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management. Compliance/ Regulatory: Review/analyze whether current products and processes (including actions or decisions conducted) comply with 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 audit to ensure that corrective and preventive actions are adequate. New Product/ Process Introduction. Partners with R&D and other cross-functional partners to ensure the proper application of design controls, risk management, and the investigation/correction of design failures/challenges. Supports new product introduction as part of design transfer. Product Quality, Control & Disposition and Performance Standards Supports activities related to the Material Review Board. Conduct investigation, bounding, documentation, review, and approval of non-conformances, CAPAs, and customer complaints. Escalation of quality issues as appropriate. ccountability and ownership for material identification, material segregation, and classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing. nalyze/review the effectiveness of preventive and corrective actions. Review root cause investigation according to an established process. ccountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality. Production/ Process Controls including Control Plans. Partners with Global Supply chain, Finished Goods, and material suppliers to ensure appropriate application 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 analyses and interpretations as part of process improvements and day-to-day support. Develop, interpret and implement standard and non-standard sampling plans. ssess the effectiveness of measurement tools, destructive tests, non-destructive tests, and measurement system analysis. ssess and interpret common versus special cause variation in manufacturing processing and determine the adequacy of current process limits. Risk Mitigation: Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond the capability of current controls or whether a change will result in potential non-compliance to a required standard such as the QSRs. ssess 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. Ensures effective quality strategies are created for the validation of test methods, processes, and design. Qualifications: minimum of a Bachelors Degree, preferably in Engineering or related technical field. Require 2 to 4 years of relevant experience. Experience working in both an FDA and European regulatory environment is required. This position will require relevant experience working in manufacturing/operations. In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required. Experience with a proven track record of implementing appropriate risk mitigation. Technical training and experience using Statistics, Lean, and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc. 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 preferred. The ability to think on the feet and provide sound judgment is highly desired. Good technical understanding of manufacturing equipment and processes is required. Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred. thorough understanding of GMP/ISO regulations and validation regulations is preferred.

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