Senior Quality Systems Manager, CAPA

We anticipate the application window for this opening will close on - 25 Apr 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 LifeWe 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).

Must Have: Minimum Requirements:

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience.

Required Knowledge and Experience: Requires broad management knowledge to lead project teams in one department.

• Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.

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 accountability for a department, function or geography
   

Innovation and Complexity: 

• Develops new objectives, new operating policies, products, processes and standards in support of the job function strategy
• Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem
   

Communication and Influence:

•  Communicates with internal and external customers and vendors concerning ongoing operations, programs or processes
• Influences across functions and businesses while balancing divergent objectives to gain cooperation of other parties
• May interact on issues that have externally divergent objectives

Leadership and Talent Management: 

• Manages at least one (department, function, geography typically comprised of other People or Program managers and / or supervisors and experienced professionals
• Recommends strategies, goals and plans for a group
• Authorizes hiring, firing, promotion and reward within own area

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

Salary ranges for U.S (excl. PR) locations (USD):$144,800.00 - $217,200.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others)

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.