Medical Device Quality Software Engineer
Bioness Medical•Santa Clarita, CA
•$140,000 - $160,000
About The Position
The Quality Assurance Software Engineer will be responsible for supporting the development, implementation, and maintenance of quality systems in accordance with FDA regulations (21 CFR Part 820), ISO 13485, and other applicable standards. This role will support product development, manufacturing, and post-market activities to ensure compliance and continuous improvement in quality processes.
Requirements
- Bachelor’s degree in engineering, Life Sciences, or related field.
- 3+ years of quality assurance experience in the medical device or regulated industry.
- Experience with embedded systems or hardware/software testing
- Experience with quality tools (e.g., root cause analysis, 5 Whys, FMEA).
- Proficiency in Microsoft Office and QMS software (e.g., MasterControl, Greenlight Guru, etc.).
- Excellent communication and documentation skills.
Nice To Haves
- Preferred knowledge of FDA QSR, ISO 13485, and risk management per ISO 14971.
- CQE, CQA, or related certification a plus.
- Experience with Class II or III medical devices.
- Familiarity with software validation and/or combination products.
- Working knowledge of EU MDR, MDSAP, and global regulatory requirements.
Responsibilities
- Support quality assurance activities across the product lifecycle, including design control, risk management, and change control.
- Conduct root cause analysis and lead CAPA investigations.
- Review and approve validation protocols (IQ, OQ, PQ), test methods, and manufacturing documentation.
- Participate in internal audits and support external audits by FDA, ISO registrars, and other regulatory bodies.
- Analyze quality data (e.g., nonconformances, complaints, trend analysis) and recommend improvements.
- Collaborate with cross-functional teams to support regulatory submissions and ensure quality compliance.
- Maintain and improve QMS procedures in alignment with regulatory requirements and company goals.
- Lead software verification & validation (V&V) activities.
- Create and execute test plans, protocols, and reports
- Perform system and integration testing (including embedded systems)
- Support risk management and quality processes (CAPA, audits)
- Help improve testing and quality processes.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
