Sr. Quality System Data Specialist

About the role

The Sr. Quality System Data Specialist will transform complex quality and operational data into actionable insights to improve product performance, patient safety, and regulatory compliance. This role combines data analytics, statistical expertise, and emerging AI technologies to support proactive quality management.

Responsibilities

• Leverage analytics, AI, and statistical methodologies to strengthen quality systems and support continuous improvement initiatives.
• Collaborate with global teams across quality, regulatory, manufacturing, service, and technology functions to identify trends and optimize decision-making.
• Build advanced dashboards, automate processes, and develop innovative analytics solutions within a highly regulated environment.
• Play a key role in improving data-driven processes and enabling teams to make informed strategic decisions.

Requirements

• 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.
• 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.