Quality Engineer

Company : CYNET SYSTEMS

Job Description:

Pay Range: $40hr – $45hr

• The Quality Engineer applies technical principles, quality science, and regulatory requirements to support product design, development, and sustaining engineering activities.
• This role ensures compliance with applicable regulatory standards, drives improvements to processes, and supports audits, documentation, and quality system activities.

Responsibilities:

• Apply technical principles, theories, concepts, and quality sciences consistently.
• Utilize strong problem-solving skills to resolve quality issues.
• Contribute measurable improvements to processes and procedures.
• Ensure design control and production/process control projects meet applicable regulatory, corporate, and unit requirements.
• Serve as a Quality representative on new product development and sustaining engineering projects.
• Review and approve new and modified design/process specifications, performance specifications, and test methods.
• Assist with supplier and internal quality system audits as part of auditor training.
• Perform additional duties as assigned.

Requirement/Must Have:

• 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).
• Knowledge of corporate or unit requirements related to quality systems.
• Ability to contribute to specific programs and projects.
• Ability to ensure quality conduct of projects, including design, data summary, interpretation, and reporting.
• Ability to revise policies and procedures.
• Ability to create and deliver presentations.
• Ability to work independently and develop approaches to solutions.
• Ability to guide and provide work direction to junior team members.
• Ability to design and perform development work independently within defined parameters.
• Experience with quality system software tools (desirable).
• Knowledge or specialization in one or more of the following:
• Acceptance sampling theory.
• Statistical process control.
• Measurement system/test method analysis.
• Quality planning.
• Failure analysis.
• Design of experiments.
• Process mapping and value stream analysis.
• Hypothesis testing.
• Descriptive statistics.
• Process capability analysis.
• Quality tools (Pareto, box plots, histograms, scatter diagrams, etc.).
• Risk management.
• Supplier quality management.
• Auditing.
• Design/development tools.
• Process validation.
• Software validation.

Qualification and Education:

• Bachelor s degree in science, engineering, or a related discipline.
• Minimum 5 years of relevant experience, or an equivalent combination of education and experience.

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