Sr Quality Systems Manager (QMS Data Analytics / AI)

Medtronic Inc.•Los Angeles, CA

35d

About The Position

In this exciting role as a Senior Quality Systems Manager, you will have responsibility for QMS Data Analytics, Data Reporting and managing multiple Digital based improvement initiatives within the Quality Transformation organization that will systematically evaluate and transform the capability of the Quality Management System (QMS) to better meet the needs of its stakeholders, both internal and external. Quality Data steward, supporting Data analysis and reporting methodologies Leading a team of Data analysts to support specific analysis where needed to perform advanced data analysis, dashboarding, and reporting in support of quality improvement goals Defining, implementing, and sustaining transformation initiatives within the Diabetes Quality Improvement Program Aligning Transformation projects with the Digital quality roadmap and providing input to the roadmap on process digitalization opportunities e.g. automation, application of AI Technologies Apply AI and machine learning concepts to real-world quality problems (e.g., anomaly detection, predictive quality, NLP for unstructured data) in partnership with data science and digital teams Partnering with the Digital Technology team to ensure alignment on roadmap, technology availability and project planning Guides the architecture, governance, and measurement of the program. Collaborate closely with the Digital Technology team and IT architects to align on system architecture, integration points, and implementation timelines Partners with key stakeholders to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System Interprets government regulations, agency guidelines, and internal policies to assure compliance. within digital transformation efforts Establishes and implements meaningful metrics, ensuring data integrity and meaningful insights for leadership Prepares quality reports and leadership communications Lead the development of user and technical requirements to support digital quality initiatives, including automation, analytics, and AI-based applications. Act as the technical product owner for digital quality initiatives-translating business needs into functional and system-level specifications Planning, resourcing, providing status for, resolving issues, and identifying project risks for multiple work streams

Requirements

Bachelor's degree in engineering, Science or Technical field with 7+ years of experience in Quality and/or Engineering OR Advanced degree in Engineering, Science or Technical field with 5+ years of experience in Quality and/or Engineering

Nice To Haves

Expertise in multiple AI Technologies and experience implementing in Quality Management Systems
Experience in Digital Transformation
5+ Years Experience in Medical Device
Program Management Certified
Strong technical background with the ability to understand and guide software/system design, integrations, and data flows.
Experience developing and managing technical requirements, system design documentation, and solution validation
Familiarity with AI/ML technologies, their applications in quality or operations, and the ability to partner effectively with data science teams
Experience with system integration (e.g., MES, ERP, LIMS, QMS, data lakes/platforms)
Understanding of quality systems, regulatory requirements (FDA, ISO), and GxP environments
Proven leadership experience in cross-functional project management, especially within digital transformation or technical quality roles
Excellent analytical, communication, and stakeholder management skills
Ability to code or script (e.g., Python, SQL) is a plus, though hands-on development is not a core responsibility

Responsibilities

Quality Data steward, supporting Data analysis and reporting methodologies
Leading a team of Data analysts to support specific analysis where needed to perform advanced data analysis, dashboarding, and reporting in support of quality improvement goals
Defining, implementing, and sustaining transformation initiatives within the Diabetes Quality Improvement Program
Aligning Transformation projects with the Digital quality roadmap and providing input to the roadmap on process digitalization opportunities e.g. automation, application of AI Technologies
Apply AI and machine learning concepts to real-world quality problems (e.g., anomaly detection, predictive quality, NLP for unstructured data) in partnership with data science and digital teams
Partnering with the Digital Technology team to ensure alignment on roadmap, technology availability and project planning
Guides the architecture, governance, and measurement of the program.
Collaborate closely with the Digital Technology team and IT architects to align on system architecture, integration points, and implementation timelines
Partners with key stakeholders to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System
Interprets government regulations, agency guidelines, and internal policies to assure compliance. within digital transformation efforts
Establishes and implements meaningful metrics, ensuring data integrity and meaningful insights for leadership
Prepares quality reports and leadership communications
Lead the development of user and technical requirements to support digital quality initiatives, including automation, analytics, and AI-based applications.
Act as the technical product owner for digital quality initiatives-translating business needs into functional and system-level specifications
Planning, resourcing, providing status for, resolving issues, and identifying project risks for multiple work streams

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).