Principal Quality Engineer

Job Title – Principal Quality Engineer

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Location - Franklin Lakes, NJ

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Duration – 9+ Months Contract

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Total Hours/week - 40.00
n1st Shift

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Job Description:

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Knowledge and Skills Set Desired Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products. Must have knowledge/specialization in one or more of the following areas o Design Control - Verification, Validation, Process Validation o Acceptance sampling theory and application o Statistical process control methods and application o Measurement system/test method knowledge and analysis o Design of Experiments o Process mapping and value stream analysis o Hypothesis testing o Descriptive statistics o Process capability analysis o Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc. o Supplier quality management o Design/development tools o Software validation

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Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and or maintenance of products or services. The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.

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Demonstrates intermediate knowledge of quality engineering policies, principles and best practices

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Demonstrates intermediate knowledge of FDA/ISO requirements

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Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity

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May act as mentor to less experienced team members

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Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision

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Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended

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Has in-depth experience, knowledge and skills in own job family Applies knowledge and skills to a wide range of standard and non-standard situations Works independently with minimal guidance Usually determines own work priorities Acts as a resource for colleagues with less experience