Senior Manager, Software Device Quality
Takeda
August 20, 2026
On-site
Lexington, MA
$137,000 - $215,270 USD yearly
Operations
About The Role
The Senior Manager, Software Device Quality supports software medical devices and combination products across the product lifecycle (design/development through manufacturing, distribution, and post-market). Ensures compliance with quality and regulatory requirements and leads key quality processes.
How you will contribute
- Partner with product development teams on quality activities across design controls (risk management, design inputs/outputs, verification/validation, design transfer)
- Provide quality oversight/approval for change control (design updates, enhancements, bug fixes, 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 for compliance and product quality
- Own/maintain risk management files per ISO 14971
- Support document control and ensure QMS compliance
- Lead/support regulatory inspections and audits (ISO 13485, MDSAP, MDR, and other global requirements)
- Support complaints, CAPA, deviations, field actions, and vigilance reporting
- Drive inspection readiness and continuous improvement in the QMS
What you bring to Takeda
- Bachelor’s degree in Engineering or related technical field (required)
- 7+ years’ experience in Quality Assurance/Engineering in medical devices and/or combination products
- Knowledge of global regulations/standards (ISO 13485, MDSAP, ISO 14971, MDR/MDD, 21 CFR Part 820)
- Experience with regulatory submissions and commercial product development
- Experience with external manufacturing partners; strong investigation and root cause analysis
- Strong cross-functional collaboration and project/program management
Preferred
- Advanced degree; experience in pharma/biotech/medical devices; software medical device/Quality IT background; auditor certification
Core Competencies
- Technical expertise; leadership; decision-making; collaboration; innovation; adaptability
The Senior Manager, Software Device Quality supports software medical devices and combination products across the product lifecycle (design/development through manufacturing, distribution, and post-market). Ensures compliance with quality and regulatory requirements and leads key quality processes.
How you will contribute
- Partner with product development teams on quality activities across design controls (risk management, design inputs/outputs, verification/validation, design transfer)
- Provide quality oversight/approval for change control (design updates, enhancements, bug fixes, 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 for compliance and product quality
- Own/maintain risk management files per ISO 14971
- Support document control and ensure QMS compliance
- Lead/support regulatory inspections and audits (ISO 13485, MDSAP, MDR, and other global requirements)
- Support complaints, CAPA, deviations, field actions, and vigilance reporting
- Drive inspection readiness and continuous improvement in the QMS
What you bring to Takeda
- Bachelor’s degree in Engineering or related technical field (required)
- 7+ years’ experience in Quality Assurance/Engineering in medical devices and/or combination products
- Knowledge of global regulations/standards (ISO 13485, MDSAP, ISO 14971, MDR/MDD, 21 CFR Part 820)
- Experience with regulatory submissions and commercial product development
- Experience with external manufacturing partners; strong investigation and root cause analysis
- Strong cross-functional collaboration and project/program management
Preferred
- Advanced degree; experience in pharma/biotech/medical devices; software medical device/Quality IT background; auditor certification
Core Competencies
- Technical expertise; leadership; decision-making; collaboration; innovation; adaptability