Note: The job is a remote job and is open to candidates in USA. CooperSurgical is a leading fertility and women’s healthcare company dedicated to supporting patients through various healthcare moments. The Data Engineer Lead - PMS & QA is responsible for leading data analysis and reporting of Medical Device performance and Post Market Surveillance activities, ensuring compliance and continuous improvement in quality assurance processes.
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
Skills
- 6+ years experience in medical device and/or pharmaceutical industries
- 4+ years experience working with data analytics, coding, evaluating trending data, and drawing insights to make strategic decisions
- Bachelor's degree in mathematics, statistics, data analytics, engineering or relevant field is required
- 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
- Medical device industry experience preferred
- Specific experience with complaint data analytics in the medical device industry preferred
- Certification in statistical techniques preferred
Benefits
- Medical coverage
- 401(k)
- Parental leave
- Fertility benefits
- Paid time off for vacation, personal, sick and holidays
- Multiple other perks and benefits
Company Overview
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