Senior Manager, Software Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the software quality function for product software, firmware, cloud infrastructure, and the digital health platform.

• Recruit, mentor, guide, and develop a team of software quality engineers.

• Ensure the completeness and adequacy of design requirements, architecture specifications, detailed design specifications, code review evidence, verification and validation evidence, risk management files, and traceability.

• Chair or supervise software change control boards and defect management processes.

• Communicate verification and validation outcomes, software quality status, risks, and mitigation strategies to management and senior leadership.

• Foster strategic alignment with R&D, Regulatory, Operations, Security, Marketing, and Clinical organizations.

• Keep abreast 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 timely delivery of investigations, CAPAs, and audit responses.

• Maintain and enhance software development, testing, and change management procedures along with digital health platform practices.

• Guarantee compliant validation of manufacturing and test system software.

• Act as a senior subject matter expert during internal audits and external regulatory inspections.

• Ensure efficient and comprehensive design history files that demonstrate compliance.

• Organize and support cross-functional initiatives during field actions.

• Lead projects that strengthen software quality processes, tools, and metrics.

⛳️ Requirements

• Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering, or a related field.

• Over 8 years of experience in the medical device industry.

• At least 3 years of prior team management experience.

• Extensive knowledge of software development principles.

• Familiarity with ISO 13485, IEC 62304, FDA QMSR, ISO 14971, and cybersecurity requirements.

• Proven experience in developing software or firmware within the medical device sector.

• Experience in software quality leadership.

• Proficient in IEC 62304 requirements.

• Technical skills in software development, preferably in C or C#.

• Capability to evaluate code reviews, software defects, verification outcomes, and CAPA conclusions.

• Strategic quality planning, risk management leadership, and audit expertise.

• Ability to lead strategic initiatives and provide technical direction for complex software investigations, CAPAs, quality decisions, and development-related risk assessments.

• Willingness to travel up to 25% of the time.

🏝️ Benefits

• Discretionary annual bonus.

• Opportunities for professional growth and development.

• Competitive compensation package.

• Flexible remote work arrangement.

• Chance to collaborate with international partners and cross-functional teams.