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Design Control and Quality Assurance Engineer
2 months ago
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
