Irvine, California, United States
Onsite
Not Available
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The Senior Quality Systems Manager provides leadership and oversight for Quality Management System (QMS) activities with primary responsibility for Corrective and Preventive Action (CAPA) governance, audit readiness, and compliance initiatives. This role leads the CAPA team and partners with cross-functional stakeholders to drive the effectiveness of quality programs, strengthen quality system performance, support regulatory inspections, and ensure compliance with applicable regulatory and internal requirements.
Primary Responsibilities
Lead the CAPA program, including CAPA review board activities, risk escalation, performance monitoring, prioritization, and oversight of timely and effective CAPA execution and closure.
Provide leadership, coaching, and direction to the CAPA team to ensure successful execution of quality initiatives, compliance objectives, and business priorities.
Oversee ongoing Quality Management System (QMS) processes and continuous improvement activities to maintain compliance and drive operational effectiveness.
Direct audit and inspection readiness activities and coordinate responses to internal, external, customer, and regulatory audit observations and findings.
Develop, maintain, and improve quality programs, systems, processes, and procedures that support compliance with applicable regulations, standards, and company policies.
Partner with business and functional teams to evaluate process performance, identify compliance risks, and implement sustainable process improvements.
Monitor quality system metrics and trends, communicate performance results to leadership, and drive actions that improve quality system effectiveness.
Coordinate quality-related support for legal, regulatory, and government inquiries while promoting best-practice sharing and standardized quality processes across the organization.
Required Qualifications (Must Have)
Bachelor's degree and 7+ years of relevant quality, compliance, or quality systems experience with 5+ years of people leadership experience; OR
Advanced degree and 5+ years of relevant quality, compliance, or quality systems experience with 5+ years of people leadership experience.
Experience leading Corrective and Preventive Action (CAPA) governance processes, including review boards, performance metrics, risk-based prioritization, escalation management, and CAPA closure oversight.
Experience leading or supporting audits and regulatory inspections, including preparation, execution, inspector interaction, and response to findings.
Experience working within a regulated industry environment and applying Quality Management System (QMS) requirements to maintain compliance.
Experience interpreting and implementing regulatory, governmental, and quality system requirements within business processes.
Preferred Qualifications (Nice to Have)
Experience within the medical device, pharmaceutical, biotechnology, or other highly regulated industries.
Experience using TrackWise or comparable electronic Quality Management System (eQMS) platforms.
Experience developing and delivering quality system, compliance, or process improvement training programs.
Proficiency with Microsoft Visio for process mapping, workflow design, and documentation.
Lean Green Belt, Design for Reliability and Manufacturability (DRM) Green Belt, or similar continuous improvement certification.
Experience applying Agile methodologies and leading cross-functional process improvement initiatives.
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.
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.
U.S. Work Authorization & Sponsorship
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.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.
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.
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
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.
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