Description/Comment: • 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
Numbers & Facts
Location
Southport, CA
Industry
Other/Not Classified
Company Size
100 to 499 employees
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.