Quality Engineer

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Company: Cynet Systems

Location: Irvine, CA 92620

Description:

Job Description:

Pay Range: $44.70hr- $49.70hr

Responsibilities:

Perform Quality Engineering activities related to product development and existing product support.
Ensure NPD processes comply to the quality system and applicable regulatory standards.
Conduct DHF gap assessment to identify and assess risks.
Develop and implement effective mitigation strategies to address risks.
Remediate risk management and design control files.
Maintain relevant quality documentation.
Develop and execute test methods, validations, and qualification plans.
Support design change and facilitate process transfer from development to production.
ssist with non-conformance resolution.
nalyze complaints and conduct Benefit-Risk assessment.
Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing.

Education and Experience:

Bachelor's degree in engineering required.
2-4 years' experience required.
Relevant experience in product development, quality assurance, and/or related fields.
Knowledge and understanding of Engineering and Quality principles, theories, and concepts.
Understanding of ISO 13485.
Experience developing, updating, and maintaining technical content of risk management files.
Print reading skills.
Understanding of statistical techniques.
Experience using statistical software (Minitab, JMP) a plus. CAD experience (Solidworks -or- Creo) a plus.
Experience in test method development, including validation and/or fixture development.
Understanding of medical device operations and/or manufacturing processes.
Solid problem-solving, organizational, analytical, and critical thinking skills.
Good documentation, communication (e.g., written and verbal) skills.
bility to build productive working relationships and interact professionally with all organizational levels.
bility to manage competing priorities in a fast-paced environment.