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Form of workNPD Quality Engineer
In conjunction with the NPD team, plan, develop and execute equipment, software, test method and/or process validation strategy.
Perform risk management by identifying, estimating, evaluating, controlling and monitoring risk, utilizing risk tools such as Process Failure Modes and Effects Analysis (pFMEA)
Author or approve protocols and reports for Equipment Qualifications (IQ/EQ), Software Validation (SV), Test Method Validation (TMV), Process Validation (OQ/PQ)
Review and evaluate specifications, drawings, quality agreements, customer documents and other documents as necessary to support NPD projects
Plan, coordinate and oversee Test Method Development and Validation activities, initiate inspection plans for new/revised product
Develop test methods or work with the Metrology team to recommend equipment, sampling plans, and measurement techniques for inspection specifications
Perform measurement system analysis (MSA) Gage 1, Gate Repeatability and Reproducibility (GRR), Bias and Linearity, Resolution and Stability studies
Perform statistical analysis of inspection data, process characterization, design of experiments (DOE) results, ANOVA, Capability Analysis
Author and execute Quality Plans for Quality Management Systems and Organizational Objectives project
Initiate and perform root cause analysis, using statistical and capability analysis to solve problems
Adhere to the company Quality Systems (QS) and approve QS doocuments
Review and insure compliance with QMS of all validations documents and records
Support Engineering, Manufacturing and Inspection personnel in design, methods, tooling, validations and other areas related to the control of product
Communicate with customers on clarification of specifications, completing customer documents, complaints, process changes and other projects as needed
Understand regulatory requirements (e.g. ISO13485, 9001, 14971, FDA 21 CFR 9210)
Provide periodic work direction to QA Inspector and Quality Engineering Technicians
Support other quality activities as necessary such as customer complaint (CC) and RMA system per procedures, corrective and preventive activities (CAPA)
Support internal and external audits
Other duties as assigned
