RAQA Data Analyst will use technical expertise and a solid understanding of quality and regulatory business processes and needs to turn data into insightful information. The data analyst will work closely with various business teams to collect, clarify, and translate business data requirements into data solutions, reports and analytics as required.
Requirements
- Hands-on experiences in analytics with proficiency in SQL, Python with the ability to efficiently extract data from multiple sources and utilize BI tool for visualization and reporting.
- Proven analytical, problem solving, and critical thinking skills, with expertise in data visualization and data mining tools to translate data into actionable insights.
- Experience of generating dashboards under shared computing environments such as EDW/Snowflake.
- Experience with advanced programming in R for tool development and reporting is highly desirable.
Responsibilities
- Develop and deliver data solutions to support RAQA business stakeholders such as Audit, Post Market Surveillance, Product Quality/Quality Operations, Regulatory Affairs, Supplier Quality, Quality Systems and Compliance.
- Extract and analyze business data from EDW (associates with data from various source systems such as SAP, CRM, Salesforce, TrackWise, Veeva) to meet reporting and analysis requirements.
- Conduct deep dives into data sets to uncover insights related to field failures and user experience, supporting root cause analysis and issue resolution.
- Design actionable and insightful dashboards to support effective decision making and optimize data analysis processes to automate and standardize reporting.
- Transform query solutions into sustainable self-service reporting tool to drive operational efficiencies.
- Stay informed about business process changes for dashboard updates and enhancements, provide ongoing support for dashboards and reports, ensuring availability, performance, and reliability.
- Assist in the development and validation of data analysis reports to meet software verification and validation requirements.
Other
- Collaborate with key stakeholders to understand business processes, KPIs, metrics and critical needs for new requests and enhancements.
- Create user documentation for internal team reference, outlining methodology and best practices to ensure consistent processes and knowledge sharing.
- Ensure compliance with global regulatory standards while protecting intellectual property.
- Conduct ad hoc analysis as needed to support business requirements and provide necessary assistance during audits.
- Self-starter, highly organized and motivated with excellent prioritization skills managing multiple projects in cross functional collaboration.
- Effective interpersonal, communication, and presentation skills with attention to details.
- Knowledge of Quality Management Systems (QMS) and processes in compliance with global regulatory standards.
- Flexible working hours – occasionally may need to work off the normal working hours due to urgent business needs, e.g., audit support, field action investigation associated with high patient risk etc.
- Ability to travel domestically and internationally (10%) due to the nature of our business and the role.
- Working experience in medical device, pharmaceutical, regulatory, or other related industries highly preferred.
- Familiar with reporting practices across multiple regulatory agencies.
- Familiar with Intuitive products is preferred.
