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Job Description

Job Title: Manager, Device Quality Assurance for Software Medical Devices

Location: Lexington, MA – (Hybrid)

About the role:

The Device Quality Assurance Manager will:

• Guide quality management system (QMS) activities for software devices, including complaint handling, deviation/CAPA, change control, training, and document control.
• Ensure that software device quality and regulatory standards are met, including meeting FDA Part 820, IEC 62304, ISO 13485, ISO 14971, MDR, and MDSAP requirements.
• Lead continuous improvement projects for software device development, production, and quality processes.

How you will contribute:

• Guide quality management system activities for software devices, including complaint handling, deviation/CAPA, change control, training, and document control. Be a subject matter expert for these processes. Facilitate the Change Control Board and Product Support Team meetings.
• Ensure that software device quality and regulatory standards are met, including meeting FDA Part 820, ISO 13485, MDR, and MDSAP requirements.
• Lead continuous improvement projects for software device development, production, and quality processes.
• Responsible for quality assessment during supplier qualification for software devices.
• Support internal and external audits including readiness as a Subject Matter Expert on QMS lifecycle documentation for software devices.
• Provide quality assurance support for regulatory filings, where needed.

Technical/Functional (Line) Expertise

• Expert in medical device regulations including FDA Part 820, IEC 62304, ISO 13485, MDD, MDR, MDSAP, and global quality systems requirements.

Leadership

• Must be recognized as a Subject Matter Expert in their area by software device teams.
• Manage activities of self and direct/indirect s in achieving defined quality goals.

Interaction

• You will work in a team model.

Innovation

• Scientific and technical expertise to ensure analysis of complex device product data and the ability to use that information to make scientifically sound Quality risk-based recommendations.

What you bring to Takeda:

• Bachelor’s degree in engineering or equivalent technical discipline.
• At least 5 years of experience working with medical devices and combination products in a regulated healthcare industry, with 5+ years of quality assurance and quality engineering roles;
• Knowledge of global quality system requirements for medical devices including 21 CFR Part 820, ISO 13485, MDR, and MDSAP.
• Experience supporting FDA, Notified Body, and other regulatory inspections.
• Experience with commercial development and regulatory filings
• Experience in continuous improvement projects and methodologies.

Desired:

• 
  Software medical device or computerized systems experience.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Professional development opportunities
• Tuition reimbursement

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply

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EEO Statement

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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time