Senior Manager, Software Quality Assurance
About The Position
The Senior Manager, Software Quality Assurance leads the software quality function for product software, firmware, cloud infrastructure, and digital health platform services. The role applies hands-on software development knowledge to ensure that software is designed, developed, verified, validated, and released in compliance with applicable quality system procedures. It provides strategic and operational leadership to software quality engineers, drives continuous improvement in software quality processes, and ensures robust risk management across the software lifecycle. The role partners with cross-functional stakeholders, contributes to design history file content, and, within areas of expertise, leads post-market product investigations and CAPAs and provides audit support. It is a full-time remote position that may include up to 25% travel.
Requirements
- Bachelor of Science in Computer Engineering, Computer Science, Electrical Engineering, or a related field.
- At least 8 years of medical device experience.
- At least 3 years of prior team management experience.
- Deep knowledge of software development principles, ISO 13485, IEC 62304, FDA QMSR, ISO 14971, and cybersecurity requirements.
- Demonstrated experience developing software or firmware in the medical device industry, combined with software quality leadership experience and proficiency with IEC 62304 requirements.
- Technical capability in software development, preferably C or C#, including the ability to assess code reviews, software defects, verification results, and CAPA conclusions.
- Ability to lead quality strategy and provide technical direction for complex software investigations, CAPAs, quality decisions, and development-related risk assessments.
- Strategic quality planning, risk management leadership, and audit expertise.
Nice To Haves
- Master's degree or higher in engineering or a software-related discipline.
- Software development experience in C or C#.
Responsibilities
- Recruit, mentor, coach, and develop software quality engineers.
- Lead software and firmware quality for product software, cloud infrastructure, and the digital health platform.
- Ensure design requirements, architecture and detailed design specifications, code review evidence, verification and validation evidence, risk management files, and traceability are complete and sufficient.
- Chair or oversee software change control boards and defect management processes; communicate verification and validation results, outcomes, and known software anomalies to management.
- Build strategic alignment with R&D, Regulatory, Operations, Security, Marketing, and Clinical organizations.
- Maintain working knowledge of program 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 timely delivery of investigations, CAPAs, and audit responses.
- Maintain and improve software development, test, and change management procedures and digital health platform management practices.
- Ensure compliant validation of manufacturing and test system software as part of new product development programs.
- Serve as a senior subject matter expert during internal audits and external regulatory inspections, and ensure complete design history files demonstrate compliance.
- Communicate software quality status, risks, and mitigation strategies to senior leadership; organize and support cross-functional efforts during field actions.
- Lead initiatives to strengthen software quality processes, tools, and metrics.
- Partner with stakeholders and contribute to design history file content; where applicable to areas of expertise, lead post-market investigations and CAPAs and provide audit support.
Benefits
- Competitive compensation.
- Professional growth and development opportunities.
- Opportunities to collaborate with international partners and cross-functional teams.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
