Staff Software Quality Engineer - Product Development

Job Summary Responsibilities

• Provide software quality leadership across multiple product development programs throughout the Software Development Life Cycle (SDLC) and Product Development Process (PDP).
• Provide quality oversight and guidance for software development, verification, validation, cybersecurity, risk management, and product release activities.
• Review and approve software lifecycle deliverables, including requirements, design documentation, traceability records, risk management documentation, verification and validation documentation, cybersecurity documentation, and software change records.
• Lead resolution of complex software quality, compliance, and risk management challenges using a risk-based approach.
• Influence key product development decisions by applying software quality engineering principles, regulatory expectations, and practical understanding of product risk.
• Facilitate quality alignment across Software Development, Product Security, Regulatory Affairs, Product Management, and Program Management functions.
• Drive consistency and improvements in software quality processes, tools, templates, and practices across product teams.
• Lead or support software risk management activities throughout the product lifecycle.
• Support complaint investigations, CAPA activities, audit observations, software nonconformances, and corrective action initiatives.
• Provide quality guidance for cloud-enabled, cybersecurity-related, AI-enabled, and data-driven software solutions, as applicable.
• Assess emerging technologies, development methodologies, and industry trends to identify quality and compliance improvement opportunities.
• Develop and promote best practices, guidance materials, and reusable quality frameworks that improve organizational effectiveness.
• Mentor and coach Software Quality Engineers and cross-functional stakeholders on software quality processes, regulatory expectations, and risk-based decision making.
• Act as a trusted advisor within the Software Quality organization, helping shape future quality capabilities, operating practices, and organizational best practices.
• Support internal and external audits and act as a subject matter expert for software quality-related topics.
• Identify organizational risks, quality concerns, and process improvement opportunities, escalating as appropriate.
• Contribute to strategic initiatives that strengthen software quality capabilities across the organization.
• Support other areas of the Quality System and perform additional tasks as defined by management.

Preferred Education

• Bachelor s degree in Computer Science, Software Engineering, Bioinformatics, Biomedical or related discipline

Job Requirements

• 8+ years of experience in software quality engineering, software development, systems engineering, or a related discipline within a regulated industry.
• Working knowledge of applicable regulations and standards, including IEC 62304, ISO 13485, QMSR, FDA regulations, and software risk management practices.
• Strong understanding of software verification, validation, risk management, cybersecurity, and quality system requirements.
• Experience supporting regulated software products, including Software as a Medical Device (SaMD), cloud-based software solutions, or complex software-enabled systems.
• Demonstrated ability to influence technical and business decisions without direct authority.
• Experience leading complex cross-functional initiatives involving multiple stakeholders.
• Experience mentoring engineers or cross-functional partners on software quality practices and regulatory expectations.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent verbal and written communication skills with the ability to communicate effectively across technical and non-technical audiences.
• Experience supporting internal and external regulatory inspections and audits preferred.
• Quality and/or Regulatory Certifications (ASQ, AAMI, RAPS, etc.) preferred.
• Occasional travel may be required.
• Willingness to work in shifts to support the US region (No night shift required).

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