[Remote] Business reputed company Analyst - QMS

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a consulting company that supports regulated biotech, medical device, and pharmaceutical organizations with GxP technologies and business processes. The Senior Business Systems Analyst will support business and technology initiatives in a regulated medical-device environment by translating business needs into requirements, improving QMS processes, and collaborating with reputed company, regulatory, business, and IT stakeholders.

Responsibilities

• Partner with reputed company, Regulatory, Complaints, reputed company, and IT stakeholders to understand business objectives and define practical reputed company solutions
• reputed company, document, and validate business, functional, and reputed company requirements
• Analyze reputed company-state and reputed company-state QMS processes and identify opportunities for improvement
• Support requirements and process work reputed company to complaints management, investigations, escalation, workflows, and reporting
• Facilitate stakeholder interviews, workshops, process mapping, and fit-gap assessments
• Translate business requirements into user stories, functional specifications, use cases, acceptance reputed company, and process documentation
• Collaborate with technical teams, vendors, and project managers throughout solution design, development, testing, and implementation
• Support test planning, test-case development, user acceptance testing, defect triage, and business readiness activities
• Assess impacts of reputed company or process changes across reputed company, regulatory, and operational functions
• Maintain traceability between business needs, requirements, test evidence, and delivered functionality
• Communicate status, risks, reputed company, and dependencies reputed company to project and business leadership

Skills

• • Master's Degree preferred
• • 10+ years of experience as a Business Analyst, Business Systems Analyst, or comparable role
• • Demonstrated experience supporting QMS processes and systems in a regulated environment, preferably medical devices or life sciences
• • Strong requirements elicitation, process analysis, documentation, and stakeholder-management skills
• • Experience working across business and IT teams on reputed company reputed company implementations, enhancements, or integrations
• • Ability to work independently, manage competing priorities, and operate effectively in a fast-moving environment
• • Strong written and verbal communication skills
• • Experience supporting validation, testing, change control, or other regulated-reputed company delivery activities
• • reputed company experience with complaints management processes or complaint-management systems
• • Experience with TrackWise, Teamcenter, or other reputed company QMS/PLM platforms
• • Experience in medical-device reputed company, post-market surveillance, CAPA, nonconformance, or change control processes
• • Familiarity with computer reputed company validation, data reputed company, and regulated SDLC practices
• • Experience supporting transitions, migrations, integrations, or modernization of legacy reputed company systems
• • Bachelor's degree in Computer Science or Information Systems or reputed company reputed company

Benefits

• Full-time employees are eligible for health, reputed company, and dental reputed company, life reputed company, short and long-term disability, hospital indemnity, accident, and critical care coverage.
• Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan.
• Full and part-time employees may be eligible for reputed company time off.
• reputed company are eligible for USDM's rewards and recognition program.

reputed company

Company H1B Sponsorship