2882 IT & Software Developer jobs in the US
Quality Lead, Software Compliance
$62,400 - 83,200
Eliassen Group
Walkers Brook Drive 55, LASARA
$62,400 - 83,200
Requirements
Must:
- Bachelors degree in a technical field
- 5 to 7 years of relevant experience
- Proficiency in interpreting FDA guidelines and translating them into Standard Operating Procedures (SOPs)
- Familiarity with Quality Management Systems and risk management for enterprise computer systems
- Strong collaboration skills to engage with diverse teams
- Proven ability to maintain compliance, demonstrate technical expertise, and exhibit good judgment
- Experience leading validation activities and guiding teams accordingly
- Capability to develop workflow and deployment diagrams
- Previous experience in Quality roles for large-scale enterprise systems like SAP, Cloud PLM, Oracle, or Camstar
- Advanced understanding of the Software Development Life Cycle (SDLC)
- Background in a regulated environment with experience in team leadership or management preferred
- Quick learner of technical terminology with effective communication skills with software engineering and IT teams
Responsibilities
- Oversee the Quality Management System ensuring adherence to FDA and international standards
- Act as the Quality Lead throughout the software development lifecycle on various projects
- Draft and guide documentation related to SDLC, including GxP, Part 11, requirements, validation plans, test scripts, and summary reports
- Provide clear guidance on testable requirements and corresponding test strategies
- Collaborate and support software development and IT teams in compliance required by FDA
- Conduct assessments of regulatory gaps and implement necessary updates to the Quality Management System
- Develop system and functional risk assessments along with validation deliverables
- Create and maintain enterprise system maps and engineering deployment/network diagrams
- Formulate and approve intricate test case and automation scripts, offering validation assistance
- Assist in planning, scripting, and reporting for data migration
- Support IT infrastructure for enterprise systems covering implementation, deployment, and ongoing maintenance
- Communicate quality guidance effectively to small teams, peers, and management
- Promote and facilitate continuous enhancement of quality processes and procedures
Description
We are seeking a Quality Lead to enhance and uphold our Quality Management System while ensuring compliance with FDA and international regulations across enterprise software projects. This position will involve authoring SDLC deliverables, leading validation and risk activities, and providing expert quality guidance to our IT and software teams. Our aim is to support complex enterprise systems, foster continuous improvement, and collaborate across functions to achieve regulatory and business goals. This role is remote, and we offer a comprehensive benefits package, including medical, dental, and vision coverage, a 401k with company matching, and life insurance. Join our diverse and inclusive team at Eliassen Group as we leverage technology and consulting expertise to create positive impacts within our communities.
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