Avani Tech Solutions Private Limited
Senior Quality Engineer
Avani Tech Solutions Private Limited, Franklin Lakes, New Jersey, us, 07417
Talent Acquisition Executive | Talent Acquisition
Qualifications and Experience:
Typically requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline and a minimum of 5 years relevant experience or a combination of equivalent education and relevant experience.
Key Skills and Knowledge:
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.
Applied knowledge of Corporate and/or Unit requirement.
Able to contribute to the completion of specific programs and projects.
Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers
Quality planning
Failure analysis investigation
Design of Experiments
Process mapping and value stream analysis
Hypothesis testing
Descriptive statistics
Process capability analysis
Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc.
Supplier quality management
Auditing
Design/development tools
Process validation
Software validation
Seniority Level Associate
Employment Type Contract
Job Function Quality Assurance
Industry Medical Equipment Manufacturing
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Typically requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline and a minimum of 5 years relevant experience or a combination of equivalent education and relevant experience.
Key Skills and Knowledge:
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.
Applied knowledge of Corporate and/or Unit requirement.
Able to contribute to the completion of specific programs and projects.
Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers
Quality planning
Failure analysis investigation
Design of Experiments
Process mapping and value stream analysis
Hypothesis testing
Descriptive statistics
Process capability analysis
Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc.
Supplier quality management
Auditing
Design/development tools
Process validation
Software validation
Seniority Level Associate
Employment Type Contract
Job Function Quality Assurance
Industry Medical Equipment Manufacturing
#J-18808-Ljbffr