Job Description

About the role

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.

How you will contribute

• 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

What you bring to Takeda

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

Core Competencies

• 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 Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
Lexington, MA

U.S. Base Salary Range:
$137,000.00 - $215,270.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in 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, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Locations
Lexington, MA

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time

Job Exempt
Yes