Data Analyst (Medical Device Quality)

Job Title: Data Analyst (Medical Device Quality) Location: Remote (U.S.) Employment Type: Contract (W2 Only) Duration: 9+ Month Contract Salary/Rate $37 -$42 per hour (W2). Pay rate will be based on factors such as experience, qualifications, skill set, geographic location, and applicable business considerations, consistent with all federal, state, and local pay transparency laws. Benefits This is a contract (W2) opportunity. Employer-provided benefits are not included unless otherwise specified by the staffing provider. Job Summary We are seeking a detail-oriented Data Analyst to support quality and operational excellence initiatives within a regulated medical device environment. This individual will be responsible for developing and maintaining statistical trending processes, analyzing quality data, identifying meaningful trends, and presenting actionable insights to cross-functional teams and leadership. The ideal candidate has a strong foundation in statistics, advanced Microsoft Excel capabilities, and experience working with quality data in the medical device industry. Experience with complaint handling, Power BI, and medical device quality system regulations is highly preferred. Responsibilities • Develop, implement, and maintain statistical data trending processes using sound statistical methodologies. • Analyze large datasets to identify trends, patterns, and opportunities for quality improvement. • Create dashboards, reports, and visualizations using Microsoft Excel and Power BI. • Perform statistical analyses to support quality metrics, CAPA activities, complaint investigations, and continuous improvement initiatives. • Partner with Quality, Regulatory, Manufacturing, Engineering, and other cross-functional teams to provide analytical support. • Present findings and recommendations to management and executive leadership in a clear and concise manner. • Ensure data integrity, consistency, and accuracy across reporting processes. • Support quality system reporting and metrics in compliance with medical device regulations. • Analyze complaint data to identify recurring issues and potential product or process improvements. • Assist in establishing standardized reporting methodologies and KPI tracking. • Document analytical methods, assumptions, and reporting procedures. Required Qualifications • Bachelor's degree in Statistics, Mathematics, Data Analytics, Engineering, Computer Science, Life Sciences, or a related field. • 3+ years of experience in data analysis, business analytics, quality analytics, or a related role. • Strong foundation in statistical analysis and statistical process trending. • Advanced proficiency in Microsoft Excel, including Pivot Tables, Power Query, advanced formulas, charts, and data analysis functions. • Excellent analytical and problem-solving skills. • Strong verbal and written communication skills. • Ability to communicate effectively with technical teams and executive leadership. • Excellent organizational skills with strong attention to detail. Preferred Qualifications • Experience within the medical device industry. • Experience processing or analyzing medical device complaint data. • Experience using Power BI for dashboard development and reporting. • Knowledge of FDA Quality System Regulation (21 CFR Part 820) and/or ISO 13485. • Experience supporting Quality Management Systems (QMS). • Familiarity with CAPA, Nonconformance, Complaint Handling, and Post-Market Surveillance processes. • Experience working in a highly regulated environment. Work Requirements • Fully remote position within the United States. • Must be authorized to work in the U.S. without sponsorship. • W2 employment only; no C2C or third-party candidates. • Ability to work standard U.S. business hours. • Occasional virtual meetings with cross-functional teams. Equal Opportunity Employer We are an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected characteristic. Application If you have a strong statistical background, advanced Excel expertise, and experience supporting quality initiatives within the medical device industry, we'd love to hear from you. Apply today with your updated resume.