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

Are you passionate about driving quality excellence and ensuring compliance in a fast-paced, innovative environment? Medtronic is seeking an experienced Senior Quality Systems Manager to join our dynamic team in Irvine, CA. In this pivotal role, you will provide critical oversight for the development and maintenance of our quality programs, systems, and processes, ensuring our products and services consistently meet the highest internal and external standards.

As a key leader, you’ll bring your expertise in regulatory requirements, audit management, and process analysis to help us achieve and maintain global compliance. You’ll collaborate with cross-functional teams, lead audit and inspection activities, and champion best practices that support our mission of transforming healthcare worldwide. If you’re ready to make a significant impact and help shape the future of quality at Medtronic, we’d love to hear from you!

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

• 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.

• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.

• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.

• Co-ordinates legal requests in support of government investigations or litigations.

• Ensures the quality assurance programs and policies are maintained and modified regularly.

• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

Required Knowledge and Experience: 

Requires a Baccalaureate degree 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.

Preferred qualifications:

• Proven audit experience, including preparation, execution, and response to findings
• Strong knowledge of Quality Management Systems (QMS) and related compliance standards
• Experience developing and delivering training programs for quality initiatives
• Proficiency with Visio for process mapping and documentation
• Hands-on experience with TrackWise or similar quality management software
• Familiarity with Agile methodologies and practices
• Solid quality background within regulated industries (e.g., medical device, pharma, biotech)
• Lean Green Belt or Design for Reliability and Manufacturability (DRM) Green Belt certification
• Demonstrated ability to drive process improvements and implement best practices

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 contribution