Data Analyst

Role: Data Analyst (Remote)

• Job Summary
• We are seeking a detail-oriented and analytical Data Analyst with strong expertise in statistics and data trending, preferably within the medical device industry. The ideal candidate will have experience analyzing complex datasets, identifying trends, and developing robust data trending processes from the ground up. This role requires excellent communication skills, the ability to collaborate with cross-functional teams, and a solid understanding of regulated quality systems.

• Key Responsibilities
• Develop, implement, and maintain data trending and analytics processes using sound statistical methodologies.
• Analyze and interpret complex datasets to identify trends, patterns, and actionable insights.
• Perform advanced data analysis using Microsoft Excel, including pivot tables, formulas, statistical functions, and data visualization.
• Review and analyze medical device complaint data to identify product quality and performance trends.
• Design and maintain dashboards and reports using Power BI (preferred) to support business and quality objectives.
• Support Quality and Regulatory teams by providing data-driven insights for compliance, risk management, and continuous improvement initiatives.
• Present analytical findings and recommendations to cross-functional teams and senior leadership.
• Ensure data accuracy, integrity, and compliance with applicable regulatory and quality requirements.

• Required Qualifications
• Bachelor's degree in Statistics, Mathematics, Data Analytics, Engineering, Life Sciences, or a related field.
• Strong foundation in statistical analysis and data interpretation.
• Advanced proficiency in Microsoft Excel for data analysis and reporting.
• Experience developing data trending methodologies and analytics processes from the ground up.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong verbal and written communication skills with the ability to interact effectively across all levels of the organization.
• Experience working in a regulated medical device environment.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and medical device quality systems.
• Experience handling and analyzing medical device complaint data.

• Preferred Qualifications
• Experience creating interactive dashboards using Power BI.
• Familiarity with quality metrics, CAPA, complaint investigations, and post-market surveillance data.
• Experience supporting quality, regulatory, or compliance initiatives within the medical device industry.

• Preferred Experience
• 3–7+ years of experience in data analytics, quality analytics, or statistical analysis, preferably within the medical device or regulated healthcare industry.
• Proven experience translating complex data into meaningful insights that support quality and business decision-making.