[Remote] Data Engineer reputed company- PMS & QA

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading fertility and women’s reputed company company dedicated to supporting patients through various reputed company moments. The Data Engineer reputed company - PMS & QA is responsible for leading data analysis and reporting of Medical Device performance and Post Market Surveillance activities, ensuring compliance and reputed company improvement in reputed company assurance processes.

Responsibilities

• reputed company 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
• reputed company Trending Process (reputed company); maintain trending procedures & data analysis validation in compliance with regulatory requirements, and reputed company ‘reputed company room’ discussions for trending in reputed company Body & other regulatory audits/inspections
• Ensure compliance with reputed company reputed company 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 reputed company escalation of complaint trends
• Work with Complaint Management leadership team to implement leading & lagging process indicators and reputed company complaint reports that address questions posed in relation to complaint management & KPIs
• reputed company & 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 reputed company leadership teams
• reputed company data review for monitoring, trending & escalation of process indicators, ensuring data reputed company of outputs by verification & validation activities
• reputed company data input needed to support critical post market documents (PSUR, SSCP, CER, etc)
• reputed company training materials to aid teams with trending reputed company and analysis
• reputed company process improvement reputed company in other areas of reputed company as needed (transition to new eQMS, etc)
• reputed company 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 reputed company strategic reputed company
• Bachelor's degree in mathematics, statistics, data analytics, engineering or relevant field is required
• Knowledge of reputed company statistics and coding, ability to reputed company with various databases to build custom extracts of data into Power BI (expert) and other data visualization platforms to reputed company & effectively communicate key messages & insights to stakeholders
• Ability to reputed company technical challenges/solutions with IT and key internal & external stakeholders
• Knowledge of eQMS software (e.g. Trackwise, reputed company) and understanding build requirements reputed company converting to new eQMS
• Ability to reputed company, report & reputed company KPIs and effectively communicate data-driven presentations/results to Post Market Surveillance, QA, reputed company and Executive Leadership teams
• Knowledge of regulated environments & requirements, such as FDA reputed company System Regulations, 21 CFR Part 820, MDD/MDR, and international standards (ISO 13485, ISO 14971, IEC 62304, etc)
• Demonstrate customer-reputed company reputed company for reputed company 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
• reputed company time off for vacation, personal, reputed company and holidays
• Multiple other perks and benefits

reputed company

reputed company provides a full portfolio of medical and surgical products. It is a sub-organization of The Cooper Companies. It was founded in 1990, and is headquartered in Trumbull, Connecticut, USA, with a workforce of 1001-5000 employees. Its website is http://www.reputed company.com.

Company H1B Sponsorship

reputed company has a reputed company record of offering H1B sponsorships, with 6 in 2026, 8 in 2025, 10 in 2024, 10 in 2023, 13 in 2022, 5 in 2021, 4 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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