Quality Data Analyst
San Diego Metro Area, California
* Conducts deep dive QS data analysis including statistical and data mining, provides interpretive results to variety of customers.
* Work closely with QA engineers to review and evaluate the adequacy of the existing fields in Nonconformance, CAPA and complaint QS database.
* Manage, create and maintain standard reporting using the centralized reporting module.
* Assist in executing OQ/PQ protocols for validating ETQ reliance.
* Ensure continued system compliance to applicable electronic QMS system regulations and standards. (ISO 13485:21012, 21 CFR part 820, & Part 11)
* The individual will collaborate with Quality System and IT to roll out new functionalities and adhere to the industry standards and change management procedures, enterprise policies, site procedures and work instructions.
* Solid knowledge of Platforms. Software/ tools such as SAP, Excel and Tableau
* Conduct data and process analysis using a variety of query tools including SQL or MS Access.
* Manages multiple priorities and successfully completes multiple projects with minimal supervision from the manager.
* Collaborate with the system help desk/ IT and Implementation consultants to resolve minor ETQ system issues.
All listed responsibilities are deemed key functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
* Knowledge of general database concepts and Experience at an enterprise-level with some level of expertise in Quality Management that supports FDA/Regulatory Compliance, Non- conformance and CAPA systems.
* Previous experience using Tableau and EtQ Reliance is highly preferred.
* Basic knowledge of Python language is preferred.
* Strong Reporting, monthly metrics, reports, data analysis, trending skills and understanding of statistical data analysis
* Proficient in Microsoft Office applications required.
* Experience with business process improvement techniques and methodologies.
* Strong management information systems, database, analytical, planning, organizational, and problem solving abilities.
* A motivational person who can influence project stakeholders, building consensus that leads to an outcome.
* Strong ability to present ideas and information in group settings. Has the ability to persuade, negotiate, and facilitate improvement.
* Strong organizational skillsets, high level of accuracy and very detailed oriented approach to projects required.
BS/BA in Computer Science, Engineering or life sciences, Business Administration, Quality, or related field.