The Global Post-Market Surveillance (PMS) Data Management position is responsible for managing all data management tasks for the PMS 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: PMS, training, audits, management review, document control and risk management

· Works closely with the PMS and cross functional plant Quality Management teams to determine the most adequate way to track and trend complaints data

· Analytical reporting- responsible to run PMS data and complaint rate 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 PMS data and shares with Global cross functional Quality and Regulatory Teams

· Performs lot analysis on PMS 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 PMS data

· Prepares for and assists with leading the product performance trend meetings (weekly FACTS meeting)

· Prepares and Leads Quarterly Global Country Calls and presents on current PMS 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

Work Experience Requirement:

Number of Overall Years Necessary: 2-5

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

Education Requirement

Bachelors 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