Senior QMS Validation Systems Analyst

Diamond Search Recruitment are delighted to be representing our client, a respected Healthcare leader. Recruiting for a Senior QMS Validation Systems Analyst, Salesforce. 

The Senior QMS Validation Systems Analyst, Salesforce is a critical member of the International IT Quality and Regulated Validated Systems team with a broad set of responsibilities but focusing Salesforce based system. Working in a dynamic, collaborative team environment, the successful candidate will be responsible for leading validation activities for the CRM International program, as well as other international Quality Management Systems (QMS) and Programs through business processes requirements, analysis of business problems, analytics, proposal/design/implementation of technical solutions, and continued development of the partnership.  The Senior QMS Validation Systems Analyst will focus on projects, enhancements and processes related to international validated system focusing on validation activities. The ideal candidate will have a demonstrated ability to provide validation guidance, as well as comprehend business process and context, while also having great writing skills to support validation documentation.

Responsibilities:

• Work with stakeholders in the QARA organization, IT, business partners and vendors to deliver and maintain validated solutions that comply with, Procedures, and the US and International regulations it relates to medical devices.
• Perform complex business and systems analysis work; conduct requirements gathering/analysis via information gathering sessions with business users and technical staff. Develop supporting process flows.
• Conduct analysis of existing business processes; recommend process improvements.
• Lead creation of Business and Functional Requirements, use cases, scenarios, process flows, system interface diagrams, test protocols and test reports.
• Provide validation expertise and guidance as it relates to any validation documentation or activity.
• Create Validation Plans, Validation Summary Reports, Test Protocols, Test Summary Reports and other validation deliverables as needed
• Communicate effectively with business users and other stakeholders

Required Education and Experience:

• Minimum of Bachelors degree in Biomedical, Chemical Engineering, Pharmaceutical or similar discipline.
• 5 years of experience working in a regulated industry
• 3 years of experience working with Quality Management System(s) in the Medical Device or Pharmaceutical industry
• 3 years of experience working on projects or programs related to Quality/Regulatory groups as it pertains to Medical Device/Pharmaceutical industry
• 4 years of experience in modeling user requirements and processes in graphical forms such as Current State and Future State models.

Skills/Competencies:

• Self-sufficient, flexible, and motivated team player capable of managing several activities simultaneously.
• Ability to work in a deadline focused, dynamic environment, consistently produce deliverables within agreed upon timelines.
• Ability to analyze business processes, design process improvements, and train business users to the new processes.
• Ability to work independently & on multiple projects against deadlines.



For a confidential discussion, contact us, or apply today!

Diamond Search Recruitment is acting as an Employment Agency regarding this vacancy.