Sr. Analyst Quality Systems

The Quality Analyst for Digital Quality be responsible for managing the sustainability aspects of the EQMS Program. This role will collaborate cross functionally with various areas of the organizations to develop a deep understanding of how our EQMS is enabling digital execution of our Quality Systems’ Processes. The successful individual must have a combination of analytical skills, project management understanding, and business acumen with an ability to think enterprise-wide. The Analyst would be comfortable with interacting with upper management and enforcing standards.Key Responsibilities:

• System Enhancement Management: Manages and monitors queue of enhancement requests for EQMS Program across all active and existing Quality Systems.
• Requirement Analysis and Management: Is able to assess business needs of a quality functional area, including but not limited to determining how the requirements gathered and interpreted from enhancement requests will improve current process and EQMS user experience.
• Collaboration: Work across functions to understand the nuances of our quality system processes across the organization. Seek to understand the data and digital process needs of our stakeholders. Work closely with the Quality Data Management, Quality Data Analytics, business process owners, and QMIT organizations to manage the progress of system enhancement execution.

• Ability to capture and document functional, technical and non-functional requirements for electronic solutions. Ensure the test strategy and test plans adequately cover the requirements. Define acceptance criteria, create use cases and perform acceptance testing. Assist in defect resolution.
• Be able to read and understand data dictionaries for Enterprise Quality Systems across all Quality areas
• Be able to contribute to data source identification, data mapping, functional design and detail design
• Be able to design and configure systems to execute features, integration, and reporting - moderate to advanced Excel skills (pivot tables and vlookups)
• Ability to develop functional specifications for system features and reports
• Document technical design and requirement definition documents that will be used to implement features and reports
• Using reporting tools and querying languages such as: SQL
• Must have strong documentation skills
• Ability to adapt to new technologies and a rapidly changing environment
• Ability to interface with multiple stakeholders at the same time and provide updates to Sr. Director level management

• Experience managing small projects
• Experience in the medical device, pharma, biotech, or healthcare related industries
• Experience with electronic Quality Management Systems (e.g. ETQ Reliance, Pilgrim)
• Knowledge and experience with Quality Systems (e.g. CAPAs, NCRs, Complaints)
• Good written and verbal communication skills
• Results-oriented, positive “can-do” attitude with demonstration of appropriate urgency and initiative
• Detail-oriented, producing high quality work
• Strong ability to manage and work with different cultures and nationalities
• Ability to manage competing and evolving priorities in a fast-paced environment
• Ability to adapt to new technologies and rapidly changing environment
• Participate in project communications, training materials, and business procedures/documentation

• Bachelor's Degree in related field with at least 2 years of experience with business analytics; OR Master’s degree focused on Business Analytics or Computer Science
• IIBA (International Institute of Business Analytics) certification (any level) is desired