Senior Manager, Software Quality Assurance

Job not on LinkedIn

🔥 10 minutes ago

🇺🇸 United States – Remote

💵 $150k - $175k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

LivaNova

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏭 Manufacturing

🏥 Healthcare

🧬 Biotechnology

Manufacturing • Healthcare • Biotechnology

LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. With a focus on medical devices, neuromodulation, and cardiac surgery, LivaNova offers advanced technologies and breakthrough treatments that provide meaningful solutions for patients, healthcare professionals, and healthcare systems. Headquartered in London and active in over 100 countries, LivaNova emphasizes bringing both clinical and economic value to its customers, being recognized as a market leader in cardiopulmonary and neuromodulation solutions.

📋 Description

• 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

• 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

• Discretionary annual bonus • Professional growth and development • Competitive compensation • Remote work arrangement • Opportunity to collaborate with international partners and cross-functional teams

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume