We anticipate the application window for this opening will close on - 2 May 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

We are seeking an experienced and detail-oriented Sr. Manager Quality Systems – CAPA to lead and manage our Corrective and Preventive Action (CAPA) program. This role is critical in ensuring that all preventive actions, non-conformances, deviations, and quality issues are addressed effectively and that systemic improvements are identified and implemented. The ideal candidate will have a strong background in quality systems, regulatory compliance, and root cause analysis within regulated industries such as medical devices, pharmaceuticals, biotechnology, or manufacturing. This position reports to the Director of Quality Systems for the Operating Unit (OU) and will be responsible for the CAPA team. This position is located in the greater Los Angeles area and it is an onsite position with the possibility of becoming hybrid (3 days onsite).

Responsibilities may include the following and other duties may be assigned.

• Manage the end-to-end CAPA process, including initiation, investigation, root cause analysis, action planning, implementation, effectiveness checks, and closure.
• Ensure CAPAs are completed within established timelines and meet regulatory and internal requirements.
• Collaborate with cross-functional teams to drive timely and effective resolution of quality issues.
• Lead root cause analysis efforts using tools such as 5 Whys, Fishbone, FMEA, or Fault Tree Analysis.
• Maintain CAPA records in compliance with company SOPs and applicable regulatory standards (e.g., FDA, ISO 13485).
• Prepare and present CAPA reports, metrics, and status updates to senior management and during audits or inspections.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Train and mentor staff on CAPA procedures and best practices.
• Continuously improve CAPA processes to enhance efficiency, compliance, and product quality.
• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Co-ordinates legal requests in support of government investigations or litigations.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

PEOPLE MANAGEMENT FUNCTIONAL CAREER STREAM: Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

DIFFERENTIATING FACTORS

Autonomy: Manages large team which would typically consist of both experienced professionals and managers.
Turns the department strategy into a commercial reality by developing, communicating and implementing business plans to achieve business results .
Receives assignments in objective oriented terms; has latitude to reinterpret objectives.

Organizational Impact: Initiates programs or projects based on identified business and / or tactical needs.
Decisions impact projects or operations, affect the deadlines, resources, and funds, and the achievement of organizational objectives.
Typically has budget or P&L accou