Quality Systems Manager

• →Provides leadership and oversight for the development, implementation, and maintenance of Quality System programs, processes, and procedures to ensure compliance with internal policies, regulatory requirements, and applicable standards.
• →Leads and develops a team of Quality Engineers and Quality Systems Specialists responsible for supporting Quality System activities across the operating unit.
• →Provides oversight of the CAPA program, partnering with CAPA owners to ensure investigations are thorough, corrective and preventive actions are appropriate, and CAPAs progress effectively and within established timelines.
• →Provides expertise and guidance in interpreting Quality System policies, regulatory requirements, standards, and internal procedures to support ongoing compliance across the organization.
• →Leads audit and inspection readiness, preparation, and execution, including coordination of audit activities, engagement with internal subject matter experts, and communication with auditing groups and inspectors.
• →Oversees the resolution and timely closure of audit and inspection findings, including ensuring appropriate ownership, response plans, corrective actions, and follow-up activities are established and completed.
• →Partners directly with operating entities and cross-functional stakeholders to assess Quality System processes, identify areas for improvement, and ensure requirements are consistently implemented.
• →Leads and supports periodic management reviews by coordinating stakeholder inputs, reviewing Quality System performance and metrics, developing management review content, and presenting information to organizational leadership.
• →Oversees implementation of new or revised enterprise Quality System procedures and requirements, ensuring the operating unit evaluates changes and effectively incorporates applicable requirements into its processes.
• →Provides oversight for Quality System training administration, procedure implementation, periodic reviews, and other activities necessary to maintain an effective and compliant Quality Management System.
• →Monitors Quality System performance, trends, KPIs, and compliance activities to identify risks, improvement opportunities, and areas requiring additional support or training.
• →Leads or supports Quality System improvement initiatives and special projects.
• →Promotes consistent Quality System standards and best-practice sharing across the organization while fostering a culture of quality, accountability, collaboration, and continuous improvement.

• Bachelors degree with 5 years of relevant experience OR Masters degree with 3 years of relevant experience
• Direct CAPA experience
• Strong audit management experience, ideally having directly run audits.
• Working knowledge of applicable medical device regulations, standards, and Quality Systems requirements.

• FDA inspection or Notified Body auditing experience
• Medical device or pharmaceutical industry experience.
• People leadership experience

• Promote an inclusive, accountable, responsive, and continuous- improvement culture 

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

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.

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 

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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

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.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.