Sr. Quality System Data Specialist

Team: IT

Location: US

Commitment: Full-time

Workplace Type: remote

Accountabilities

The Sr. Quality System Data Specialist will be responsible for leveraging analytics, AI, and statistical methodologies to strengthen quality systems and support continuous improvement initiatives. This role requires close collaboration with cross-functional stakeholders to deliver meaningful insights and scalable solutions.

• Act as a subject matter expert in statistical methods, supporting quality teams with appropriate approaches to evaluate product performance and quality indicators.
• Develop and maintain dashboards, scorecards, and visualizations to identify trends, anomalies, and emerging quality signals.
• Analyze complex datasets and communicate findings clearly to both technical and non-technical audiences.
• Support management reviews, quality reporting activities, and data-driven decision-making processes.
• Identify opportunities to apply artificial intelligence and automation to improve signal detection, reporting efficiency, and knowledge management.
• Evaluate emerging AI technologies and recommend practical applications within regulated business processes.
• Support the implementation, testing, validation, and monitoring of AI-enabled solutions.
• Collaborate with IT and business stakeholders to improve data accessibility, integration, and quality.
• Work with multiple data sources, including complaint systems, CAPA platforms, ERP systems, manufacturing databases, and customer feedback tools.
• Partner with global quality and regulatory teams to understand business needs and deliver analytics solutions.
• Provide guidance and training on data interpretation, dashboard usage, and analytical best practices.
• Contribute to continuous improvement initiatives focused on enhancing quality system effectiveness.

Requirements

The ideal candidate is an experienced data and analytics professional with strong statistical knowledge, technical expertise, and the ability to translate complex information into business insights.

• Bachelor’s or Master’s degree in statistics, data science, biostatistics, mathematics, or a related field, or equivalent combination of education and experience.
• Minimum of 5 years of relevant experience in data analytics, data science, healthcare analytics, medical device quality, or similar fields.
• Strong understanding of descriptive statistics, statistical trend analysis, hypothesis testing, risk-based monitoring, and data visualization techniques.
• Ability to interpret complex datasets, identify meaningful trends, and communicate analytical concepts effectively.
• Strong problem-solving skills with a high level of attention to detail.
• Knowledge of Generative AI, Large Language Models (LLMs), machine learning fundamentals, NLP, predictive analytics, and responsible AI principles.
• Ability to identify practical AI applications that improve business processes and operational efficiency.
• Experience with analytics and data platforms such as Power BI, Tableau, SQL, Python, R, Microsoft Fabric, Databricks, Snowflake, Azure analytics tools, Microsoft Copilot, or similar technologies.
• Strong communication skills and ability to collaborate effectively within global, cross-functional teams.
• Experience working in regulated industries such as healthcare, medical devices, quality systems, or compliance environments is preferred.
• Curious mindset with a passion for emerging technologies, innovation, and continuous improvement.

Benefits

• Competitive compensation based on location.
• United States salary range: $105,000 - $130,000 base salary plus a 10% annual bonus.
• Health, dental, and vision insurance benefits.
• 401(k) plan with company match.
• Paid time off.
• Wellness initiatives and health assistance resources.
• Life insurance coverage.
• Short-term and long-term disability benefits.
• Health and dependent care flexible spending accounts.
• Commuter benefits.
• Parental and caregiver leave.
• Tuition reimbursement opportunities.
• Remote work flexibility.