Senior Manager, Software Device Quality

Takeda • Lexington, MA

1d • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• Advanced degree
• Experience in pharmaceutical, biotech, or medical device industries
• Software medical device or Quality IT background
• Auditor certification

Responsibilities

• 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

Benefits

• medical, dental, vision insurance
• a 401(k) plan and company match
• short-term and long-term disability coverage
• basic life insurance
• a tuition reimbursement program
• paid volunteer time off
• company holidays
• well-being benefits
• up to 80 hours of sick time per calendar year
• up to 120 hours of paid vacation for new hires

What This Job Offers

• Job Type: Full-time
• Career Level: Senior