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Job Description

Job Title: Quality Engineer – Software Medical Device

Location: Lexington, MA

About the role:

Software Device Quality Engineer is an experienced Quality and Technical professional who develops and has stewardship of the overall device and combination product quality strategy to maximize the benefit and sustainability of Takeda’s in-line products and to bring Takeda’s pipeline products to a sustainable existence on the market.

• Ensure Quality support is provided for the change control process for software devices.
• Ensure Quality support is provided for the Design History File (DHF)
• 
  Provide input for any regulatory filings for medical devices and combination products
• 
  Develop Technical Files for Software as Medical Devices (SaMD)
• Responsible for oversight of Validation and Verification for SaMD
• Ensuring Quality support is provided for the design and development process, including risk management according to ISO 14971 requirements, for SaMD.
• Ensure appropriate training relating to software devices is defined for the design and development and product support teams.
• Ensure Quality support is provided for the documentation process relating to SaMD.
• Ensure support for ISO 13485 certification, MDSAP, MDR and other Health Authority Regulatory Audits for software application devices and/or combination products.

How you will contribute:

• Act as the Deputy Person Responsible for Regulatory Compliance (PRRC) for TPUSA and Shire HGT
• Own and maintain the design control and other related procedures for software application medical devices.
• Ensure QMR support, submission and approval is provided for the software devices in production including complaints, CAPA/Deviations, field corrective actions, and medical device ing.
• Identify ways to improve the efficiency and effectiveness of processes as part of the Quality Management System (QMS) for software devices meeting changing business needs and regulatory/quality requirements.
• Support Device Regulatory Affairs in creating/identifying technical information for 510(k), Technical Files and other regulatory submissions.
• Support related QS initiatives, such as inspection readiness, ISO 13485 certification, and integration projects. Build strong working relationships with Device QA partners and other business process owners including cross-functional colleagues located both in the US and internationally.
• Partner with the product development team, including managing activities for risk management, quality planning, design input, design output and design transfer

What you bring to Takeda:

• Bachelor’s Degree in BS in Engineering or equivalent technical discipline required, and 5+ years of experience working with medical devices and/or combination products in a regulated healthcare industry, with experience in Quality Assurance and/or Quality Engineering roles;
• Expert knowledge of international regulations for Device and Combination Products with a full understanding of European, International, and US requirements for Design Control and Risk Management guidelines, Change Management, CAPA, etc. primarily emphasis on ISO 13485:2016, MDSAP, ISO 14971, and 21 CFR Part 4, 820, 803.
• Strong background in Medical Device Regulation (MDR) and Medical Device Directive (MDD)
• Experience with clinical development and regulatory filings
• Experience working with external manufacturing partners; assessing root cause analysis and effective investigation practices; strong operations background to ensure value added and effective quality operations; experience driving out inefficiencies and improving turnaround times; understanding of GDPs
• Experience through interacting and collaborating with cross-functional global teams; project/program management and operational excellence preferred;

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 training and 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. In this role, 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, as necessary.
• 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