Principal Software Quality Assurance Engineer (Remote - United States)
Ladders · United States
- Hybrid
- Full-time
- $170,000 / year
- United States
Tailored resume — keyword-matched to this role.
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Job highlights
- Lead quality assurance for medical device software.
- Ensure regulatory compliance and risk management.
- Influence architecture and technology capabilities.
- Requires advanced degree and 5 years experience.
- Remote role within the United States.
About the role
About the Role
We are seeking a Principal Software Quality Assurance Engineer to join a leader in the Healthcare space. This role will lead technical initiatives focused on scalable systems, platform reliability, and meaningful business transformation. You will work across engineering, product, operations, and business stakeholders to translate complex requirements into practical technology solutions. The position offers the opportunity to influence architecture, execution quality, and the technology capabilities that enable long-term growth within a healthcare environment.
Responsibilities
- Lead software assurance activities across the medical device software life cycle.
- Conduct physical and functional configuration audits and review software requirements.
- Ensure compliance with regulatory requirements and elevate major software issues to management.
- Act as a quality champion for software product development and testing teams.
- Support software-related processes including CAPA and cybersecurity risk management.
Qualifications
- Master's degree or higher in relevant fields and 5 years of software quality assurance experience in medical device, aerospace, or automotive industries; OR Bachelor's degree in relevant fields and 7 years of software quality assurance experience in medical device, aerospace, or automotive industries.
- Working knowledge of premarket and postmarket medical device regulations and standards (e.g., FDA, ISO 13485, IEC 62304).
- Experience in developing and testing software systems, including SaMD and embedded software, with documentation skills.
- Excellent communication skills and strong problem-solving ability.
Benefits
- Programs to support physical and financial well-being.
- Competitive pay and benefits benchmarked against similar companies.
- Potential relocation assistance available.
Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.
Key skills/competency
- Principal Software Quality Assurance Engineer
- Medical Device Software
- Software Quality Assurance
- Regulatory Compliance
- FDA Regulations
- ISO 13485
- IEC 62304
- Software Development Lifecycle
- CAPA
- Cybersecurity Risk Management
Skills & topics
- Software Quality Assurance
- Principal Engineer
- Medical Device Software
- Regulatory Compliance
- FDA
- ISO 13485
- IEC 62304
- CAPA
- Cybersecurity Risk Management
- Remote
- Healthcare
- Quality Assurance
- Software Testing
- Embedded Software
- SaMD
- Aerospace QA
- Automotive QA
How to get hired
- Tailor your resume: Highlight medical device QA, regulatory compliance, and leadership experience.
- Showcase regulatory knowledge: Emphasize familiarity with FDA, ISO 13485, and IEC 62304.
- Demonstrate problem-solving: Prepare examples of leading technical initiatives and stakeholder collaboration.
- Address remote work: Confirm US-based status and readiness for a remote Principal QA role.
Technical preparation
Master the software QA lifecycle in medical devices.,Study FDA, ISO 13485, IEC 62304 standards.,Prepare to discuss SaMD and embedded software.,Review CAPA and cybersecurity risk management.
Behavioral questions
Describe leading technical QA initiatives.,How do you ensure regulatory compliance?,Share an experience elevating software issues.,How do you collaborate with cross-functional teams?
Frequently asked questions
- What are the key regulatory standards for this Principal Software Quality Assurance Engineer role at Ladders?
- For this Principal Software Quality Assurance Engineer position at Ladders, key regulatory standards include FDA regulations, ISO 13485, and IEC 62304, particularly relevant for medical device software.
- What specific experience is required for the Principal Software Quality Assurance Engineer position?
- Candidates need a Master's degree and 5 years of QA experience in medical devices, or a Bachelor's with 7 years, focusing on software quality assurance within regulated industries.
- Is this Principal Software Quality Assurance Engineer role remote and where?
- Yes, this Principal Software Quality Assurance Engineer role is fully remote, but candidates must be based within the United States.
- What kind of technical initiatives will a Principal Software Quality Assurance Engineer lead?
- The Principal Software Quality Assurance Engineer will lead initiatives focused on scalable systems, platform reliability, and driving business transformation through practical technology solutions in healthcare.
- Does Ladders offer visa sponsorship for the Principal Software Quality Assurance Engineer position?
- No, Ladders does not offer visa sponsorship for this Principal Software Quality Assurance Engineer position. Candidates must be legally authorized to work in the United States.
- What are the core responsibilities of a Principal Software Quality Assurance Engineer at this company?
- Core responsibilities include leading software assurance, conducting audits, ensuring regulatory compliance, managing CAPA, and supporting cybersecurity risk management for medical device software.