Senior Global Quality Data Analyst I

Summary

The Global Quality Data Management Analyst position is responsible for managing all data management tasks for the Quality and Regulatory Affairs organization in order to monitor the overall performance of the QMS related to product performance across the lifecycle of the device and to proactively determine actions plans as applicable. The primary responsibility is to perform trend analysis activities, data mining and reporting, as well as working on delivering various quality reports and assisting other groups such as Design Assurance, Quality Assurance, Engineering, Operations, New Product Development, Marketing and Business Units – in management of end user customer experience and market activities, as needed.

Responsibilities

Assist with providing inputs to data management & analysis SOPs to ensure consistency and quality within data management activities related to, but not limited to: Quality System, PMS, training, audits, management review, document control and risk management

Works closely with the GQRA and cross functional plant Quality Management teams to determine the most adequate way to track and trend quality data

Analytical reporting- responsible to run Quality data and reports in accordance with the procedures utilizing BW4, Power BI, and/or excel

Using statistical techniques, this position is responsible of generating specific queries to support growing / changing business and market needs, operations and compliance activities

Prepares weekly and monthly trend reports on Quality data and shares with Global cross functional Quality and Regulatory Teams

Performs lot analysis on quality data

Performs regular and on-demand market saturation rate prediction models / estimates together with management

Perform on-demand post launch product performance analysis for spring and Change Control process

Review vigilance and other databases for relevant complaint information in support to the risk management activities

Provide regular updates to the business regarding the Quality data

Prepares for and assists with leading the product performance trend meetings (weekly FACTS meeting, monthly Monthly Management Review (MMR))

Prepares and Leads Quarterly Global Country Calls and presents on current quality trends and updates to product performance data.

Assesses and provides inputs to different Regulatory Data Analytical Databases

Support internal and external audits

Other Duties As Needed Or Required

Essential Functions of the Role**:

Very little physical effort required to perform normal job duties (unless otherwise indicated)

Must have manual dexterity (use of mouse, keyboard), to type and enter data in the computer as well for preparing presentations

Travel 10%

Work Experience Requirements

Number of Overall Years Necessary: 2-5

Experience in the medical device industry is highly preferred in the areas of data analysis, complaints, CAPA, Quality

Education Requirements

Bachelor's degree in science, engineering, statistics or related discipline

Experience with ISO 13485, 21 CFR 820, MDD / MDR, ISO 14971

Specialized Skills/Technical Knowledge

In depth knowledge of statistical tools ( SPC, trend analysis, six sigma)

Excellent oral and written communication skills

Excellent interpersonal skills

Ability to work on multiple assignments and balance priorities to meet timelines.

SAP and Excel

Microsoft Power BI Platform (M, DAX, Dataflows/cloud service, Data Modeling, and Reporting)

Problem solving skills

Mode - Hybrid

Location - Gurugram