Job Title : Software Quality Engineer Job Description
The Software Quality Engineer will actively participate in testing new products and sustaining activities for commercialized products. This role is involved in the testing and validation of Software / Firmware products in a highly regulated Medical Device environment.
Responsibilities
- Actively contribute to all aspects of Software / Firmware Quality Assurance activities.
- Develop, execute, and oversee system-level testing through comprehensive Design Validation Plans, Protocols, and Reports for neuromodulation devices.
- Log and escalate any findings or anomalies.
- Support quality assurance activities across the product lifecycle, including design control, risk management, and change control.
- Review and approve validation protocols (IQ, OQ, PQ), test methods, and manufacturing documentation.
- Participate in internal audits and support external audits by FDA, BSI, and other regulatory bodies.
- Collaborate with cross-functional teams (R&D, Regulatory, Manufacturing) to support regulatory submissions and ensure quality compliance.
- Maintain and improve QMS procedures in alignment with regulatory requirements and company goals.
- Write and execute test cases.
Essential Skills
Software quality assuranceSoftware testingSoftware validationC programmingManual systems level testing experienceSoftware developmentManual testingAdditional Skills & Qualifications
Bachelor’s degree in engineering, Life Sciences, or related field.3+ years of working experience in software testing.Understand Bluetooth technology and Mobile applications development.Excellent communication and documentation skills.Experience with Class II or III medical devices.Working knowledge of EU MDR, MDSAP, and global regulatory requirements.Knowledge of ISO standards and risk management per ISO, preferred.Work Environment
The work environment involves collaboration with cross-functional teams such as R&D, Regulatory, and Manufacturing. The role requires participation in internal and external audits and maintaining QMS procedures in alignment with regulatory requirements. The position requires excellent communication and documentation skills to ensure quality compliance and support regulatory submissions.
Job Type & Location
This is a Contract to Hire position based out of Valencia, CA.
Pay and Benefits
The pay range for this position is $55.28 - $67.31 / hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following :
Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan – Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off / Leave (PTO, Vacation or Sick Leave)Workplace Type
This is a hybrid position in Valencia,CA.
Application Deadline
This position is anticipated to close on Mar 5, 2026.