Cynet systems Inc
Job Description
Pay Range: $40.17/hr - $45.17/hr
The Quality Engineer is responsible for ensuring compliance with applicable regulatory, corporate, and unit requirements through the consistent application of quality and engineering principles.
This role contributes to new product development, sustaining engineering projects, and continuous improvement of processes and procedures to enhance product quality and regulatory compliance.
Responsibilities
Apply technical principles, theories, concepts, and quality tools to ensure product and process quality.
Demonstrate strong problem-solving skills and implement measurable improvements to processes and procedures.
Ensure design control and production/process control projects meet local, international, corporate, and unit regulatory requirements.
Represent Quality as a team member on new product development and sustaining engineering projects.
Review and approve new or modified design/process specifications, including product performance specifications and test methods.
Assist with supplier and internal quality system audits to evaluate the effectiveness of the established Quality System and manufacturing practices (Auditor-in-training).
Perform additional duties as assigned.
Knowledge and Skills
Applied knowledge of FDA medical device quality system regulations and international quality standards (21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR).
Understanding of corporate and unit quality requirements.
Ability to contribute to and ensure quality conduct of projects, including design, data interpretation, and report generation.
Skilled in policy and procedure revisions and presentations.
Capable of independently developing and implementing solutions.
Ability to guide and provide direction to lower-level project developers.
Experience working independently on design and development activities within defined parameters.
Familiarity with Client software systems utilized in Quality Systems is desirable.
Proficiency or specialization in one or more of the following areas:
Acceptance sampling theory and application.
Statistical process control methods.
Measurement systems and test method analysis.
Quality planning and process mapping.
Failure analysis and root cause investigation.
Design of Experiments (DOE).
Value stream analysis.
Hypothesis testing and descriptive statistics.
Process capability analysis.
Basic quality tools (Pareto, histograms, scatter diagrams, etc.)
Risk management.
Supplier quality management.
Auditing.
Process validation.
Software validation.
Qualification and Education
Bachelor’s degree in Science, Engineering, or a related discipline (required).
Minimum of 5 years of relevant experience, or a combination of equivalent education and experience.
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The Quality Engineer is responsible for ensuring compliance with applicable regulatory, corporate, and unit requirements through the consistent application of quality and engineering principles.
This role contributes to new product development, sustaining engineering projects, and continuous improvement of processes and procedures to enhance product quality and regulatory compliance.
Responsibilities
Apply technical principles, theories, concepts, and quality tools to ensure product and process quality.
Demonstrate strong problem-solving skills and implement measurable improvements to processes and procedures.
Ensure design control and production/process control projects meet local, international, corporate, and unit regulatory requirements.
Represent Quality as a team member on new product development and sustaining engineering projects.
Review and approve new or modified design/process specifications, including product performance specifications and test methods.
Assist with supplier and internal quality system audits to evaluate the effectiveness of the established Quality System and manufacturing practices (Auditor-in-training).
Perform additional duties as assigned.
Knowledge and Skills
Applied knowledge of FDA medical device quality system regulations and international quality standards (21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR).
Understanding of corporate and unit quality requirements.
Ability to contribute to and ensure quality conduct of projects, including design, data interpretation, and report generation.
Skilled in policy and procedure revisions and presentations.
Capable of independently developing and implementing solutions.
Ability to guide and provide direction to lower-level project developers.
Experience working independently on design and development activities within defined parameters.
Familiarity with Client software systems utilized in Quality Systems is desirable.
Proficiency or specialization in one or more of the following areas:
Acceptance sampling theory and application.
Statistical process control methods.
Measurement systems and test method analysis.
Quality planning and process mapping.
Failure analysis and root cause investigation.
Design of Experiments (DOE).
Value stream analysis.
Hypothesis testing and descriptive statistics.
Process capability analysis.
Basic quality tools (Pareto, histograms, scatter diagrams, etc.)
Risk management.
Supplier quality management.
Auditing.
Process validation.
Software validation.
Qualification and Education
Bachelor’s degree in Science, Engineering, or a related discipline (required).
Minimum of 5 years of relevant experience, or a combination of equivalent education and experience.
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