· Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools
· Conduct benchmarking to develop more effective methods for improving quality
· 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, including providing support during internal and external audits.
· Conduct periodic line audits to assess for production controls such as lot segregation. Review results to ensure that corrective and preventive actions are adequate.
New Product/Process Introduction & Qualification
· Approve IQ, OQ, PQ, TMV or Software Validation:
· 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 MRB
· Conduct investigation, documentation, review and approval of non-conformances, CAPAs and customer complaints.
· Accountability and ownership for material identification, material segregation, classification of defect types.
· Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
· Accountability and ownership of Quality metrics.
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.
· 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
· Develop, interpret and implement standard and non-standard sampling plans
· Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
· Assess and interpret common versus special cause variation in manufacturing processing
· Ensures effective quality strategies are created for the validation of test methods, process and design.
· Determine 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
· Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, etc
· A minimum of a Bachelor's Degree, preferably in Engineering or related technical field. 2-4 years related experience.
· Experience working in both an FDA and European regulatory environment is preferred.
· 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.
· This position may require up to 10% travel and will be based in an MD&D manufacturing facility.
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