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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in software quality leadership within the medical device industry, with a strong focus on compliance with ISO standards and FDA regulations. Capable of strategic quality planning, risk management, and leading cross-functional teams to enhance software quality processes.
Highest-signal resume keywords
Software Quality LeadershipMedical Device ExperienceISO 13485 ComplianceIEC 62304 ProficiencyC/C++ Software Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Software Development PrinciplesRisk ManagementVerification and ValidationCode Review AssessmentCAPA ManagementTechnical AssessmentsDesign History FilesChange Management ProceduresDefect ManagementHazard Analysis
Soft Skills
MentoringCoachingStrategic CommunicationCross-Functional CollaborationLeadership
Industry Keywords
FDA QMSRISO 14971Cybersecurity RequirementsFMEADigital Health PlatformSoftware Change ControlPost-Market Lifecycle RiskInternal AuditsExternal Regulatory InspectionsField Actions
Tech Stack
Tools & technologiesCloudCyber Security
About the role
Key responsibilities & impact- Lead the software quality function for product software, firmware, cloud infrastructure, and the digital health platform
- Recruit, mentor, coach, and develop software quality engineers
- Ensure completeness and sufficiency of design requirements, architecture specifications, detailed design specifications, code review evidence, verification and validation evidence, risk management files, and traceability
- Chair or oversee software change control boards and defect management processes
- Communicate verification and validation results, software quality status, risks, and mitigation strategies to management and senior leadership
- Build strategic alignment with R&D, Regulatory, Operations, Security, Marketing, and Clinical organizations
- Maintain knowledge of hazard analyses, FMEAs, security risk assessments, risk management reports, and post-market lifecycle risk documentation
- Approve complex investigations, technical assessments, code-related quality conclusions, and quality-critical decisions
- Ensure on-time delivery of investigations, CAPAs, and audit responses
- Maintain and improve software development, test, and change management procedures and digital health platform practices
- Ensure compliant validation of manufacturing and test system software
- Serve as a senior subject matter expert during internal audits and external regulatory inspections
- Ensure efficient, complete design history files demonstrating compliance
- Organize and support cross-functional efforts during field actions
- Lead initiatives strengthening software quality processes, tools, and metrics
Requirements
What you’ll need- BS in Computer Engineering, Computer Science, Electrical Engineering, or related field
- 8+ years of medical device experience
- 3+ years of prior team management experience
- Deep knowledge of software development principles
- Knowledge of ISO 13485, IEC 62304, FDA QMSR, ISO 14971, and cybersecurity requirements
- Demonstrated experience developing software or firmware in the medical device industry
- Software quality leadership experience
- Proficiency with IEC 62304 requirements
- Technical capability in software development, preferably C or C#
- Ability to assess code reviews, software defects, verification results, and CAPA conclusions
- Strategic quality planning, risk management leadership, and audit expertise
- Ability to lead strategy and provide technical direction for complex software investigations, CAPAs, quality decisions, and development-related risk assessments
- Up to 25% travel
Benefits
Comp & perks- Discretionary annual bonus
- Professional growth and development
- Competitive compensation
- Remote work arrangement
- Opportunity to collaborate with international partners and cross-functional teams