IT Business Applications Developer / Analyst (Trackwise or Veeva)

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position

Intuitive is seeking a highly skilled and experienced IT Developer/Analyst specializing in Quality Management Systems (QMS). This role will be responsible for supporting, developing, and administering Trackwise EQMS with a specific focus on Java based application development in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions. Additionally, they will support the development of interfaces between the EQMS system and SAP.

Essential Job Duties

1. System Support and Administration:

• Provide development support for Trackwise EQMS and other related QMS applications.
• Administer and maintain the functionality of the QMS, ensuring optimal performance and reliability.

2. Requirements Gathering and Analysis:

• Collaborate with onshore teams and stakeholders to gather business requirements related to QMS functionalities, with a focus on Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
• Analyze and translate business needs into technical specifications for system enhancements.

3. System Development and Customization:

• Develop and implement custom solutions and configurations to enhance the capabilities of the QMS in areas such as Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
• Develop and implement custom solutions and configurations to enhance the capabilities of the QMS, specifically in the development of interfaces between EQMS and SAP.
• Utilize SAP ABAP expertise to support the integration between the EQMS system and SAP.
• Collaborate with development teams to ensure seamless integration of QMS with other business systems.

4. Quality System Compliance:

• Ensure that QMS systems comply with relevant regulatory requirements in the medical device industry, especially in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
• Conduct periodic audits and assessments to verify adherence to quality standards.

5. User Training and Support:

• Provide training and support to end-users to ensure effective utilization of QMS systems.
• Troubleshoot and resolve user reported issues in a timely manner.

6. Documentation and Reporting:

• Maintain comprehensive documentation for system configurations, changes, and upgrades, specifically in the context of Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
• Generate regular reports on system performance, issue resolution, and compliance metrics.

Qualifications

Required Skills and Experience

• Minimum of 5 years of experience as a Developer/Business Systems Analyst with a focus on QMS in the medical device industry,
• Java Development and SAP ABAP experience is essential for developing EQMS applications and interfaces between EQMS and SAP.
• Expertise in supporting, developing, and administering Trackwise EQMS and similar QMS applications.
• Strong understanding of regulatory requirements related to Quality System