Principal Quality Engineer

3 weeks ago

Franklin Lakes, United States MILLENNIUMSOFT Full time

Job Title – Principal Quality Engineer

Location - Franklin Lakes, NJ

Duration – 9+ Months Contract

Total Hours/week - 40.00
1st Shift

Job Description:

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

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.

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

Demonstrates intermediate knowledge of FDA/ISO requirements

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

May act as mentor to less experienced team members

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

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

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

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