Highlights
Participates as a member of the Software Quality Assurance (SWQA) team for Client Care products that ensures digital applications produced by Client is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. Ensures compliance to relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR Part 11 and Client Diabetes Care requirements as they relate to the development, verification, validation, and maintenance of medical device software.
Numbers & Facts
| Location | Alameda, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $70 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
Title: Software Quality Engineer
Location: Alameda, CA 94502
Duration: 08/31/2026 to 08/30/2027 (12months)
Job Description:
Participates as a member of the Software Quality Assurance (SWQA) team for Client Care products that ensures digital applications produced by Client is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements.
Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software.
Coordinate activities with other engineering disciplines, departments, and contractors.
Duties:
Qualifications:
Location: Alameda, CA 94502
Duration: 08/31/2026 to 08/30/2027 (12months)
Job Description:
Participates as a member of the Software Quality Assurance (SWQA) team for Client Care products that ensures digital applications produced by Client is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements.
Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software.
Coordinate activities with other engineering disciplines, departments, and contractors.
Duties:
- Completes software quality tasks in accordance with current Quality System Requirements.
- Works independently with objectives given by SWQA Manager.
- Can plan and coordinate own work according to higher-level project schedules.
- Reviews deliverables/activities as identified in the Client Design Control Process/project plan or equivalent project plan. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports for the Alameda site.
- Ensures unexpected events, issues or software bugs which occur during verification/validation are addressed and/or processed under relevant design control and defect management procedures.
- Ensures compliance to relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR Part 11 and Client Diabetes Care requirements as they relate to the development, verification, validation, and maintenance of medical device software.
Qualifications:
- Bachelor s degree, or equivalent experience, in a scientific, technical, or engineering discipline.
- 2 to 5 years experience in Software Quality Assurance and/or Software Testing experience.
- Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements.
- Must have 1 - 3 years project experience in software quality assurance practices, methodologies including Agile and techniques, preferably in medical device software such as web and mobile applications.
- Must have excellent oral and written communication skills.
- ASQ Certifications a plus.
- Medical Device experience strongly preferred.
- Cybersecurity, medical web and mobile applications or AI experience preferred.
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.