Kelly · 1 week ago

Quality Engineer

Sacramento, CA

Full-time

Onsite

Mid Level

3+ years exp

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Responsibilities

Fulfill the Development QA / Design Assurance role on Software Product Development Core and/or Design Change Teams as the design progresses through the development lifecycle.

Collaborate with cross functional teams to ensure that the product Design History File (DHF) is auditable, traceable, concisely organized, complete, and supports regulatory product registration needs.

Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans.

Work cross functionally on defining performance requirements, conducting risk analysis, reviewing verification and validation test plans, execution, and data to complete the design transfers.

Qualification

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Agile DevelopmentDesign AssuranceQuality SystemsMedical Device RegulationsEffective LeadershipInterpersonal Skills Communication

Required

BS degree in engineering, technology, or science from an accredited college or university with 5+ years relevant experience OR

Master's degree in field with 3+ years experience OR

Doctoral degree in field with 0-2 years experience

Agile Development experience

Experience in Design Assurance (QA) supporting software/hardware development projects in Quality Systems (Design Control) and Quality Design Assurance (DHF Compliance)

Experience in medical device or other regulated industries

Effective leadership and interpersonal skills

Good written and verbal communication skills

Must be able to work in the U.S. with approved authorization status