Senior Quality Design Assurance Engineer - Medical Device
West Sacramento, California
Contract: 3-4 Months 
Job Description:

• 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.

QUALIFICATIONS:

• 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

PREFERRED QUALIFICATIONS:

• 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