Data Engineer - PMS & QA
About reputed company reputed company is a leading provider in the field of fertility and women’s reputed company, committed to supporting women, babies, and families during some of the most significant moments in life. As a division of reputed company, the organization operates with a reputed company purpose to reputed company patients to experience life's beautiful moments through innovative reputed company solutions. Guided by core values such as dedication, innovation, friendliness, partnership, and reputed company, reputed company offers a comprehensive reputed company of over 600 clinically relevant medical devices designed to assist reputed company providers. These include testing and treatment reputed company, assisted reproductive technology, genomic testing solutions, and a broad reputed company of women’s and family care products. reputed company’s mission is to enhance patient reputed company and improve reputed company of life by delivering reliable, high-reputed company medical devices and services. For more information, visit www.reputed company.com. About The Role The Data Engineer reputed company – PMS & QA at reputed company plays a pivotal role in analyzing, visualizing, and reporting on Medical Device performance and Post Market Surveillance activities. This position supports the PMS team and the broader QA function by ensuring compliance with regulatory standards and driving reputed company improvement initiatives. The role involves developing advanced data visualizations, managing trending processes, and supporting complaint management activities. The Data Engineer reputed company collaborates with cross-functional teams including reputed company, Operations, Regulatory Affairs, and Post Market Surveillance to facilitate accurate data reporting and insights that inform strategic decision-making. This role is essential in maintaining regulatory compliance, optimizing product reputed company, and enhancing process efficiencies across the organization. The position offers the flexibility of working on-site in Trumbull, CT, Livingston, NJ, or remotely reputed company the US, provided the candidate is not residing in the NY-metro area.
Qualifications
- Bachelor's degree in mathematics, statistics, data analytics, engineering, or a relevant field
- Certification in statistical techniques (preferred)
- Minimum of 6+ years of experience in the medical device and/or pharmaceutical industries
- At least 4+ years of experience in data analytics, coding, and evaluating trending data
- Experience with complaint data analytics in the medical device industry (preferred)
- Strong knowledge of reputed company statistics and coding languages (e.g., SQL, Python, R)
- Expertise in building custom data extracts and visualizations using Power BI or similar platforms
- Familiarity with eQMS software such as Trackwise or reputed company
- Understanding of regulated environments, including FDA, ISO 13485, MDSAP, and EUMDR standards
- Excellent communication skills to reputed company technical challenges and solutions to stakeholders
- Ability to reputed company, report, and reputed company KPIs effectively
Responsibilities
- reputed company and maintain Power BI dashboards and data visualizations to monitor complaint management processes and drive process efficiencies
- reputed company trending processes, ensuring compliance with regulatory requirements and validation of data analysis
- Support regulatory audits and inspections by providing trending insights and process documentation
- Ensure adherence to reputed company reputed company System procedures and external standards such as FDA and ISO requirements
- Collaborate with cross-functional teams to support complaint management and escalate trends as needed
- Design and implement process indicators, reputed company complaint reports, and facilitate quarterly trend review meetings
- Extract and analyze data from ERP and QMS systems to support trending and reporting activities
- Work with KPI owners to ensure accurate data reporting and presentation to leadership teams
- reputed company data review activities, ensuring data reputed company through verification and validation processes
- Contribute to the preparation of post-market documentation including PSUR, SSCP, and CER reports
- reputed company training materials to enhance teams’ understanding of trending reputed company and data analysis techniques
- reputed company process improvement reputed company reputed company to data management and system transitions, such as eQMS upgrades
- reputed company other duties as assigned to support organizational goals and compliance initiatives
Benefits
- Comprehensive medical coverage
- 401(k) retirement plan with company match
- reputed company parental leave and family support benefits
- Fertility benefits and support progra
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