Data Engineer Lead- PMS & QA

CooperCompanies•Trumbull, CT

1d•Hybrid

About The Position

The Data Engineer Lead - PMS & QA leads data analysis, visualization, and reporting of Medical Device performance and Post Market Surveillance activities within the PMS team as well as the broader QA function and supports CooperSurgical Complaint Management and other Quality areas by working in partnership with Commercial, Operations, Regulatory Affairs and Post Market Surveillance teams. This role helps to ensure on-going regulatory compliance and continuous product & process improvements within PMS & QA and supports CooperSurgical Complaint Management and other Quality areas by working in partnership with our Commercial, Operations (QA & Manufacturing), Regulatory Affairs and Post Market Surveillance teams.

Requirements

Knowledge of applied statistics and coding, ability to interact with various databases to build custom extracts of data into Power BI (expert) and other data visualization platforms to clearly & effectively communicate key messages & insights to stakeholders.
Ability to articulate technical challenges/solutions with IT and key internal & external stakeholders.
Knowledge of eQMS software (e.g. Trackwise, Veeva) and understanding build requirements when converting to new eQMS.
Ability to develop, report & track KPIs and effectively communicate data-driven presentations/results to Post Market Surveillance, QA, Commercial and Executive Leadership teams.
Knowledge of regulated environments & requirements, such as FDA Quality System Regulations, 21 CFR Part 820, MDD/MDR, and international standards (ISO 13485, ISO 14971, IEC 62304, etc).
Demonstrate customer-focused mindset for all internal & external interactions.
6+ years experience in medical device and/or pharmaceutical industries. (medical device industry experience preferred)
4+ years experience working with data analytics, coding, evaluating trending data, and drawing insights to make strategic decisions. (specific experience with complaint data analytics in the medical device industry preferred)
Bachelor's degree in mathematics, statistics, data analytics, engineering or relevant field is required.

Nice To Haves

Certification in statistical techniques preferred.

Responsibilities

Develop custom Power BI dashboards and data visualizations to monitor & continuously improve the Complaint Management process and ensure adherence to process requirements while driving process efficiencies.
Lead Trending Process (owner); maintain trending procedures & data analysis validation in compliance with regulatory requirements, and lead ‘front room’ discussions for trending in Notified Body & other regulatory audits/inspections.
Ensure compliance with CooperSurgical Quality System procedures and applicable external standards, including FDA, ISO 13485, MDSAP, EUMDR.
Work directly with cross-functional teams to support complaint daily management activities and timely escalation of complaint trends.
Work with Complaint Management leadership team to implement leading & lagging process indicators and develop complaint reports that address questions posed in relation to complaint management & KPIs.
Develop & implement quarterly complaint trend review meetings.
Navigate different ERP/QMS systems to extract data for analysis & trending.
Work with various KPI owners to facilitate efficient & accurate data reporting to CooperSurgical leadership teams.
Oversee data review for monitoring, trending & escalation of process indicators, ensuring data integrity of outputs by verification & validation activities.
Lead data input needed to support critical post market documents (PSUR, SSCP, CER, etc).
Develop training materials to aid teams with trending methods and analysis.
Lead process improvement projects in other areas of CooperSurgical as needed (transition to new eQMS, etc).
Perform other duties as assigned.