Design Control and Quality Assurance Engineer

1 month ago


West Sacramento, United States Compunnel Inc. Full time

We are hiring for our client in the medical devices industry.

Duration: 16 weeks

Job Type: Onsite

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
  • Supports regulatory product registration needs
  • Ensure compliance with applicable:
  • Regulatory agency requirements
  • Published standards
  • Company policies/procedures
  • Local procedures/work instructions
  • Project-specific plans

Work cross-functionally on:

  • Defining performance requirements
  • Conducting risk analysis
  • Reviewing verification and validation test plans, execution, and data
  • Completing the design transfers

Qualifications:

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

Preferred:

  • 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



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