Data Analytics Quality Manager

Edwards Lifesciences • Irvine, CA

1d

About The Position

The Data Analytics Quality Manager leads Quality System improvements, Quality Analytics Insights, and AI-enabled solutions to identify risks and trends, drive cross-functional projects and corrective actions, and strengthen operational effectiveness, compliance, and data-driven decision-making. The role supports the company’s patient-focused mission through technology and collaboration, while upholding its ethical and compliance standards.

The manager oversees small- to medium-sized Quality Systems and projects, improves processes and documentation, analyzes metrics, leads investigations and corrective actions, and prepares data and documents for audit activities. The position also leads AI initiatives, deploys AI Agents to support operations, and provides technical direction to lower-level staff.

Requirements

• Bachelor's degree or equivalent in a related field and 8 years of experience in a quality and/or manufacturing environment in the medical device industry, or equivalent work experience based on Edwards criteria; alternatively, a master's degree or equivalent in a related field and 6 years of such experience.
• Excellent documentation, communication, and interpersonal relationship skills, including negotiating and relationship management skills.
• Extensive knowledge of the role's organizational area and ability to contribute to development of new concepts, techniques, and standards.
• Extensive understanding of Edwards’ policies, procedures, and guidelines relevant to Quality Systems.
• Extensive understanding of medical device regulations, such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Ability to transfer essential knowledge and mentor team members on specialized skills.
• Excellent problem-solving, organizational, analytical, and critical-thinking skills.
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate management.
• Ability to manage competing priorities in a fast-paced environment.
• Ability to represent leadership on sections of projects within a specific area, interfacing with project managers and the Quality Systems team.
• Ability to consult in a project setting within specific sections.
• Adhere to all company rules and requirements, including pandemic protocols and environmental requirements.

Nice To Haves

• Excellence in business intelligence applications such as Power BI, Tableau, or Streamlit.
• Experience with Quality Systems, post-market, regulatory, and training data, or equivalent work experience based on Edwards criteria.
• Experience authoring and executing validation for business intelligence reports.
• Experience with databases such as Snowflake, Databricks, JDE, MES, EQMS, or LMS.
• Experience with programming languages such as SQL or Python.
• Experience architecting, developing, and deploying business intelligence, analytics, and reporting solutions for internal and external stakeholders.

Responsibilities

• Identify, lead, and provide business process improvement solutions for Quality Systems, including reviewing and approving procedural changes to improve operations, efficiency, and user experience.
• Lead moderately complex projects from inception through completion, including developing or scheduling milestones, securing and allocating resources, and representing quality management on cross-functional teams.
• Manage all phases of small- to medium-sized Quality Systems, such as Training, CAPA, NCR, Supplier, FCA, and PRA.
• Review and approve changes to Quality System documentation, assess effectiveness, and approve recommendations from others.
• Drive investigations of basic problems, conduct robust root cause analysis, develop and implement corrective actions, and establish monitoring plans with cross-functional subject matter experts.
• Review metrics and identify actions.
• Lead AI initiatives and deploy AI Agents to support operations.
• Prepare and pre-review data and documents for integrity before presentation in internal and external audits.
• Provide technical direction to lower-level staff.
• Perform other incidental duties assigned by Leadership.

Benefits

• Competitive salaries.
• Performance-based incentives.
• A wide variety of benefits programs addressing the diverse individual needs of employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager