Quality Engineering Compliance Manager
Palantir Technologies
This job is no longer accepting applications
See open jobs at Palantir Technologies.See open jobs similar to "Quality Engineering Compliance Manager" Ellis H-1B.Core Responsibilities
- Continue to develop a Palantir-wide QMS that lives under ISO 9001 and drives consolidation of process documentation and promotes process consistency at Palantir.
- Develop and maintain a Change Management software system atop Palantir Foundry that is adaptive to client requirements, whilst conforming to developer practices within Palantir.
- Periodically run Change Management meetings with key client POCs demonstrating proactive and retroactive changes to guide changes in client SOPs and trainings for client personnel.
- Support implementation and maintenance of internal software applications and systems supporting QMS processes like Document Management System and Learning Management System.
- Periodically audit developer authored unit and integration tests and work with Product Development teams to ensure maximal code coverage.
- Run Installation Qualification (IQ), Operational Qualification (OQ) and guide Performance Qualification (PQ) of Palantir Foundry system.
- Author and ensure implementation of approved procedures across the organization, setup non-conformance and CAPA processes to monitor deviations and management reporting.
- Establish and nurture inter-departmental relationships to drive key objectives such as socializing SOPs, conducting and enforcing training programs, negotiating release process with product development teams.
- Be the champion and advocate for ingrained quality across Palantir, work with product development and product reliability teams to implement GxP processes.
- Support customer enablement lifecycle, include customer and FDA audits, as well as assessment questionnaires for GxP clients.
What We Value
- A visionary who has no problem getting their hands dirty and doing the work necessary to create and improve the state of the world.
- Experience documenting SOPs and coordinating cross-functionally to maintain adherence to documented process.
- Interest in building and maturing a program, specifically in the quality space (Quality Management System and process areas within a QMS (e.g. Doc Control, Training, Supplier Management CAPA, SDLC, Change Management, etc.)).
- Experience navigating the product life cycle, as well as standard SDLC in a DevOps world.
- Thrives in a fluid, dynamic and fast-paced environment, specifically a modern SaaS company.
- Ability to connect and develop positive relationships with employees across cross-functional teams (Engineering, Compliance, Product Reliability, Product Development, among others).
- Experience in demonstrating value proposition of a quality to internal stakeholders without experience/buy-in.
What We Require
- You have at least 6+ years of relevant work experience.
- Software Development (Test) Engineering experience.
- Knowledge of FDA and EU regulatory requirements and other guidelines related to GxP activities, including 21 CFR Part 11 / GAMP 5, and supporting CSV work a plus.
- Bachelor’s degree in Computer Science, Information Systems, Management Information Systems, or related.
This job is no longer accepting applications
See open jobs at Palantir Technologies.See open jobs similar to "Quality Engineering Compliance Manager" Ellis H-1B.