Data Analytics Quality Manager
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 Edwards Lifesciences’ patient-focused mission by improving quality systems and enabling business practices that meet the company’s ethical standards. The manager leads process improvements and moderately complex projects, manages phases of small to medium quality systems, reviews and approves system documentation and changes, and drives investigations and corrective actions in collaboration with cross-functional subject matter experts. The role also leads AI initiatives and deployment of AI agents, reviews metrics, prepares data and documents for audit integrity, and provides technical direction to lower-level staff. Other incidental duties may be assigned by leadership.
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 negotiation and relationship management.
- Extensive knowledge of the employee’s area within the organization and ability to contribute to developing new concepts, techniques, and standards.
- Extensive understanding of Edwards policies, procedures, and guidelines relevant to Quality Systems.
- Excellent problem-solving, organizational, analytical, and critical-thinking skills.
- Ability to transfer essential knowledge and mentor team members on specialized skills.
- Ability to interact professionally across 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 in a specific area, interfacing with project managers and the Quality Systems team.
- Ability to consult on specific sections in a project setting.
- Ability to adhere to company rules and requirements, including pandemic protocols and environmental requirements.
Nice To Haves
- Excellent proficiency with business intelligence applications such as Power BI, Tableau, and 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, and LMS.
- Experience with programming languages such as SQL and Python.
- Experience architecting, developing, and deploying business intelligence, analytics, and reporting solutions for internal and external stakeholders.
- Extensive understanding of medical device regulations, such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
Responsibilities
- Identify, lead, and provide business process improvement solutions for Quality Systems, including reviewing and approving procedure 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 quality systems, such as Training, CAPA, NCR, Supplier, FCA, and PRA.
- Review and approve changes to Quality Systems documentation, assess effectiveness, and approve recommendations from others.
- Drive investigations of basic problems, perform robust root cause analysis, develop and implement corrective actions, and establish monitoring plans with cross-functional subject matter experts.
- Review metrics and identify actions based on them.
- Lead AI initiatives and deploy AI agents to support operations.
- Prepare and pre-review data and documents for integrity before internal and external audit activities.
- 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 for employees and their families
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What This Job Offers
Job Type
Full-time
Career Level
Manager
