GE HealthCare Senior Enterprise Application Engineer – PDx Quality 

India, Karnataka, Bengaluru 

183894291

In this pivotal role, you will collaborate closely with our Quality colleagues to shape technical roadmaps and

Essential Responsibilities:

• Implement, and maintain IT systems and software for the Quality department to ensure compliance with regulatory standards (e.g., FDA, EMA, ICH).

• Manage the investigation and resolution of IT-related issues, including system non-conformances and deviations.

• Translate unstructured or ambiguous requests into actionable technical requirements through problem decomposition and planning.

• Prioritize continuously in accordance with the understanding and validation of customer problems and needs.

• Stay updated with industry trends and regulatory changes to ensure compliance and best practices.

• Lead the implementation of new IT technologies and methodologies to enhance efficiency and accuracy.

• Own the short-term product roadmap and its integration into a larger application or strategic roadmap.

• Strong written and verbal communication skills.

Basic Qualifications:

• A Bachelor's Degree in Computer Science or “STEM” Majors (Science, Technology, Engineering and Math).

• A minimum of 6 years of relevant professional experience working in the Pharma or IT Industry including experience with Salesforce development activities.

• Proven experience in Salesforce development (Apex, Visualforce, Lightning Components, Flows).

• Hands-on experience with Salesforce architecture and integration patterns.

• Experience with Salesforce-based QMS platforms such as Trackwise Digital or Salesforce Health Cloud.

• Familiarity with Salesforce DevOps tools and CI/CD pipelines.

• Expert understanding of analysis & design and system architecture concepts.

• Expert knowledge of CSV lifecycle with understanding of GxP (GLP/GCP/GMP), 21CFR Part 11, EU Annex 11. Familiarity with audit trails, electronic signatures, and validation documentation.

• Ability to execute in a technical environment and willingness to engage and understand technical solutions, challenges and issues.

Desired Characteristics:

• Experience implementing Trackwise Digital on Salesforce platform.

• Understanding of QMS processes such as CAPA, Deviations, Change Control, and Audits.

• Ability to configure and customize Trackwise workflows and reports.

• Experience with Cloud technologies, Java, SQL, Integrations, API

• Experience working in remote / global teams.

• Ability to make technology choices based on experience and willingness to take calculated risks and experiment with newer technologies.

• Ability to develop partnership with stakeholders and develop an inclusive & collaborative environment.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.