Primary Function of Position
RAQA Data Analyst will be a member of the Quality Data Analytics (QDA) team and 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. The analyst will be heavily involved with the use, distribution, and successful delivery of data and reports on a periodic basis. The successful candidate must excel in a high-energy, focused, small-team environment with profound understanding of ISI systems, product profile as well as the company quality management system (QMS). More importantly, the qualified candidate should have good understanding of concurrent and legacy systems with extensive knowledge and hands-on experiences of using a variety of BI tools for dashboards. This role will be supervised directly under the senior manager of BI reporting in RAQA QDA team.
Essential Job Duties
- Develop and deliver data solutions in support of audit, escalation, product investigation, CAPA, field action, complaint investigations and regulatory agencies inquiries.
- Develop and deliver data solutions for dashboard, reporting and investigation needs.
- Perform under firm regulatory compliance world-wide and sensitivity to Intellectual Property protection.
- Interact with key stakeholders to understand business processes and critical needs and translate requirements to most appropriate KPIs and metrics.
- Locate business data (SAP, CRM, Sales Force, TrackWise, etc.) required include extracting data from precursor business systems used.
- Turn query solutions into sustainable self-service reporting tool to increase efficiencies.
- Integrate innovative data science approaches to automate and deliver effective solutions.
- Develop concise, insightful, and engaging dashboards that support business decision making.
- Design to streamline and implement holistic and sustainable dashboard reporting strategy.
- Develop methodologies to improve data analysis, implement dashboard automation, simplification, and standardization solutions to leverage efficiency.
- Provide continuous support and maintenance to ensure the availability and performance of developed dashboards and reports.
- Perform deep dives into data sets to provide insight on field failures and user experience in support of root cause analysis and resolution.
- Understand business process change for dashboard update and/or enhancement.
- Develop user documentation and a variety of visual representation of data analysis.
- Assist with development and validation of data analysis reports to conform with the software verification and validation requirements.
- Perform ad hoc analysis as required.
- Provide support needed during audits.
- Perform other related duties as assigned.
Required Skills and Experience
- Minimum Bachelor’s degree with 3+ years of experiences in delivering data solutioning and dashboard reporting, preferably within quality and regulatory function unit.
- Proven project leadership and management skillsets representing RAQA QDA team interfacing with various business teams on strategic project planning, user requirements, service design, solution presentation, training, etc.
- Extensive hands-on experiences in analytics, proficiency in SQL query, Python, and ability to efficiently extract data from multiple sources and utilize BI tool for visualization and reporting.
- Excellent analytical, problem solving, critical thinking and data visualization skills.
- Experience with data mining and visualization tools such as Tableau or Power BI.
- Ability to story tell and draw actionable insights from complex data.
- Experience of generating dashboards under shared computing environments such as EDW/Snowflake.
- Solid inter-person communication, presentation skills and attention to details.
- Highly organized, self-starter and highly motivated with exceptional prioritization skills managing multiple projects.
- 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.
- Purposefully onsite when required.
- Ability to travel domestically and internationally (10%) due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Required Education and Training
- Minimum Bachelor’s degree with 3+ years of experiences in delivering data solutioning and dashboard reporting, preferably within quality and regulatory function unit.
Preferred Skills and Experience
- Knowledge of enterprise applications such as SAP ECC, S/4 HANA, Salesforce, TrackWise is preferred.
- Knowledge of system data from concurrent and legacy databases is preferred.
- Experience with advanced programming such as R for tool development and reporting is a big plus.
- Extensive knowledge on QMS system and processes and knowledges of ISI products is a big plus.
- Working experience in medical device, pharmaceutical, regulatory, or other related industries highly preferred.
- Familiar with ISI products and business process knowledges.
- Familiar with reporting practices across multiple regulatory agencies.
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.