Post Market Surveillance; PMS), Business Systems Architect

Job Description

Primary Function of Position (Brief statement (3-5 sentences) describing the reporting structure, main responsibility(s) and key function(s) which will contribute to the overall success of the individual in this job)

PMS Business Systems Architect will report to PMS Operations Manager. This role will be responsible for identifying, analyzing, refining, translating, and finally documenting business requirements related to the Complaint eQMS System. This role will ensure business requirements are accurately developed and tested through authoring and executing test scripts. This role will work closely with global PMS business users and IT solution team to ensure business needs and projects are delivered.

In addition, the PMS Business Systems Architect will triage day-to-day Complaint eQMS System technical support before escalating to the IT team.

Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager)

• Assists with the review of business case documents, project plans and schedules to ensure business needs are met.
• Facilitate sessions with all relevant stakeholders to drive clarity and agreement on requirements.
• Documentation of requirements, authoring & execution of test cases and change management procedures for existing critical eQMS Complaint systems ensuring change meets (or exceeds) business objectives.
• Reviews, updates and develops documentation including but not limited to requirements, process workflows, user requirements, use cases, data mapping/validations, business rules, test scripts, and procedures for future references.
• Develops and describes a sufficiently deep and comprehensive understanding of both, the PMS business processes/objectives/outcomes and technology solutions and uses that knowledge to propose and guide business improvements.
• Performs mass update of Complaint eQMS records to process high volume of records.
• Triage day-to-day Complaint eQMS System technical support before escalating to the IT team such as troubleshooting FDA MDR Submission failures, complaint system integrations errors
• Performs other duties as assigned.