QMS Analyst

Direct Client Requirement
Role: Quality Management Systems (QMS) Analyst
Location: India Remote - potential to work in the office in the future (Hyderabad)
Work hours: 2-11 pm India hours

The QMS Analyst -will support the design, development, configuration, integration, and ongoing maintenance of Salesforce-based business applications, with a primary focus on Propel PLM functionality. This role will report into the Regulatory Compliance team and partner with Quality, Document Control, Engineering, Regulatory, Operations, and other business stakeholders to translate process needs into scalable technical solutions that support controlled product data, documentation workflows, change management, and continuous process improvement.

Key Responsibilities

• Develop, configure, test, deploy, and support Salesforce solutions using Apex, Lightning Web Components, Flows, validation rules, custom objects, reports, dashboards, permission sets, and related platform capabilities.
• Configure and support Propel PLM modules and processes, including items, bills of material, documents, engineering change orders, approvals, quality records, product releases, and related workflow automation.
• Partner with business stakeholders to gather requirements, assess process impacts, and translate functional needs into maintainable technical designs.
• Assist with QMS process monitoring by analyzing trends, identifying gaps, preparing metrics, and supporting continuous improvement initiatives.
• Assist with data migration, data cleanup, data validation, and controlled transfer of product, document, and PLM records between environments or Salesforce stacks.
• Troubleshoot production issues, perform root cause analysis, document resolutions, and implement sustainable corrective actions.
• Maintain technical documentation, configuration records, user stories, test scripts, release notes, and deployment evidence in alignment with internal procedures.
• Support system validation, change control, impact assessments, regression testing, and release management activities in a regulated environment.
• Collaborate with administrators, developers, business analysts, quality system owners, and external vendors to deliver reliable system enhancements.
• Identify opportunities to simplify workflows, reduce manual effort, strengthen data integrity, and improve user experience across Salesforce and Propel PLM.
• Maintain clear, accurate documentation of requirements, test evidence, approvals, quality decisions, and process updates in accordance with internal procedures.

• Bachelor's degree in Engineering, Computer Science, Information Systems, or a related technical discipline; equivalent experience may be considered.
• Experience developing and supporting Salesforce applications in an enterprise environment.
• Hands-on experience with Salesforce development tools and capabilities
• Experience supporting Propel PLM or a comparable PLM or eQMS,
• Understanding of software development lifecycle practices, including requirements gathering, technical design, unit testing, deployment, and post-release support.
• Ability to troubleshoot complex system issues, analyze data relationships, and communicate technical concepts to non-technical stakeholders.
• Strong documentation skills and ability to work within controlled processes, change management practices, and audit-ready environments.

• Salesforce certifications such as Administrator, Platform Developer I, Platform Developer II, or Platform App Builder.
• Experience with CI/CD tools, source control, sandbox management, release pipelines, and Salesforce deployment frameworks.
• Experience working in medical device, healthcare technology, manufacturing, life sciences, or another regulated industry.
• Familiarity with document control, engineering change management, product lifecycle management, quality records, validation, and data governance practices.
• Working knowledge of medical device regulatory requirements and quality system expectations, including FDA QMSR/21 CFR Part 820, ISO 13485, MDSAP, and related document control, design control, change control, and traceability requirements.
• Experience supporting validated systems, computer software assurance, system validation documentation, test evidence, and audit-ready release records within a regulated medical device or life sciences environment.
• Familiarity with QMS processes such as CAPA, nonconformance, complaints, supplier quality, training records, controlled documentation, and quality event workflows.
• Experience supporting software system migrations, org consolidations, data mapping, metadata comparison, and post-migration validation activities.

• Technical Problem Solving: Diagnoses issues quickly, evaluates options, and implements scalable solutions.
• Business Partnership: Works effectively with cross-functional teams to understand process needs and deliver practical system improvements.
• Data Integrity Mindset: Prioritizes accuracy, traceability, controlled records, and reliable system outputs.
• Continuous Improvement: Identifies opportunities to streamline processes, reduce rework, and improve system efficiency.
• Communication: Explains technical concepts clearly and documents decisions, configurations, and risks appropriately.
• Ownership: Takes accountability for assigned development tasks, support tickets, documentation, and deployment readiness.