Senior Manager, Software Device Quality

The Senior Manager, Software Device Quality is a seasoned quality and technical leader responsible for supporting software medical devices and combination products across the full product lifecycle – from design and development through manufacturing, distribution, and post‑market support. This role ensures compliance with all applicable quality and regulatory requirements and provides leadership across key quality processes.

• Partner with product development teams to lead quality activities across design controls, including risk management, design inputs/outputs, verification/validation, and design transfer
• Provide quality oversight and approval for change control activities, including design updates, enhancements, bug fixes, and infrastructure changes
• Maintain Design History Files (DHF) and Technical Files
• Support global regulatory submissions and approvals for software and combination products
• Oversee verification and validation activities to ensure compliance and product quality
• Own and maintain risk management files in accordance with ISO 14971
• Support document control processes and ensure QMS compliance
• Lead or support regulatory inspections and audits (ISO 13485, MDSAP, MDR, and other global requirements)
• Provide quality support for complaints, CAPA, deviations, field actions, and vigilance reporting
• Drive inspection readiness and continuous improvement initiatives across the QMS

• Bachelor’s degree in Engineering or related technical field required
• 7+ years of experience in Quality Assurance/Engineering within medical devices and/or combination products
• Strong knowledge of global regulations and standards (ISO 13485, MDSAP, ISO 14971, MDR/MDD, 21 CFR Part 820)
• Experience with regulatory submissions and commercial product development
• Experience working with external manufacturing partners and driving effective investigations and root cause analysis
• Strong cross‑functional collaboration and project/program management experience
• Preferred: advanced degree
• Preferred: experience in pharmaceutical, biotech, or medical device industries
• Preferred: software medical device or quality IT background
• Preferred: auditor certification

• Technical Expertise: strong scientific and analytical skills to assess complex data and make risk‑based quality decisions
• Leadership: ability to influence, build relationships, and drive results across global, cross‑functional teams
• Decision‑Making: confident decision‑making in complex and ambiguous environments, with a focus on continuous improvement
• Collaboration:
  
  proven ability to partner effectively across functions and geographies
• Innovation: drives process improvements through product and quality insights
• Adaptability: thrives in dynamic environments and effectively manages complexity and change

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.