Date Posted: 10/13/2025
Hiring Organization: Rose International
Position Number: 489964
Industry: Healthcare
Job Title: Principal Software Quality Engineer
Job Location: Bellevue, WA, USA, 98005
Work Model: Hybrid
Work Model Details: Onsite 2-3 days/week
Shift: 8 AM to 5 PM Pacific Time, 40 hours/week.
Employment Type: Temp to Hire
FT/PT: Full-Time
Estimated Duration (In months): 7
Min Hourly Rate($): 80.00
Max Hourly Rate($): 85.00
Must Have Skills/Attributes: Azure, FDA, Medical device, Quality Engineer
Experience Desired: Cloud hosting experience - Azure preferred (8 yrs); Software Quality in the medical device industry (8 yrs)
Required Minimum Education: Bachelor’s Degree
**C2C is not available**
Job Description
Required Education:
• Education: B.S./M.S. in a relevant engineering field (e.g., biomedical, software, electrical).
Required Skills:
• Experience: 8+ years of progressive Quality Engineering experience in the medical device industry with hands-on hardware and software support.
• Regulatory Knowledge: Must have experience with FDA CFR 820, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
• Technical Skills: Proficient in statistical analysis (e.g., Minitab) and Microsoft Office.
• Soft Skills: Exceptional communication, problem-solving, and attention to detail. Must be able to manage multiple projects in a fast-paced environment.Preferred Qualifications
• Certifications: ASQ CQE, Six Sigma Black Belt/Green Belt.
• Experience with Artificial Intelligence (AI), AAMI TIR45, SaMD (Software as a Medical Device), and cloud infrastructure.
Role & Responsibilities
• Design Control: Reviewing and approving the Design History File (DHF).
• Risk Management: Leading the development of the Risk Management File (RMF), including dFMEA, pFMEA, and hazard analysis.
• Software Quality: Acting as the Subject Matter Expert (SME) for software quality, including code reviews, security analysis, and software Bill of Materials (BOM).
• Verification & Validation: Providing guidance on statistical methods and reviewing test protocols and reports.
• Compliance: Ensuring adherence to FDA and ISO standards (e.g., ISO 13485, ISO 14971, IEC 62304).
• Problem Solving: Supporting the resolution of anomalies like software bugs and cybersecurity vulnerabilities.
Logistical & Administrative Information
• Work Schedule: 8 AM - 5 PM Pacific Time, 40 hours/week.
• Time Sheets: Weekly, Time in/Time out. - **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
- **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
The interactions that I have had with your representatives have always been prompt and very professional. I am very pleased and impressed with your company and services.
Sioe, Consultant
Rose International has been great to me. I thank everyone there for all of their hard work; it has not gone unnoticed.
Melody, Consultant
It is a great pleasure being a part of the Rose International Team.
Toni, Consultant
I have been very pleased with my experience with Rose International. Everyone that I encountered was very helpful and courteous.
Stephanie, Consultant
Rose is an assembly of people grounded in honesty, truth and dignity for all of its employees and contractors.
Samba, Consultant
EMPLOYEE COMMENTS