Senior Manager, Software Device Quality

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

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

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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.

#GMSGQ

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:

U.S. Base Salary Range:

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.

For information about our benefits, please click here.

EEO Statement

Job Exempt