Santa Ana, California, United States of America, United States of America
Onsite
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.
In this role as a Senior Quality Systems Specialist, you will provide oversight for the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies and external regulatory standards. You will serve as a key liaison during audits and inspections, lead audit readiness activities, and support ongoing Quality Management System (QMS) improvements.
You will support all internal and external audits, including FDA inspections, Notified Body audits, and other regulatory inspections, ensuring a high state of inspection readiness and effective execution.
As a Quality Systems leader, your day is dynamic and impactful, encompassing:
Key Responsibilities
Oversee the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance.
Interpret and apply internal policies, regulatory, and governmental requirements to maintain compliance.
Collaborate with operating entities to perform process analysis and ensure adherence to regulations.
Lead and support all audit and inspection activities, including FDA inspections, Notified Body audits, and internal audits; manage audit preparation, execution, and resolution of findings.
Serve as primary liaison with auditors and inspectors throughout all audit stages.
Prepare reports and required documentation (e.g., CAPAs) for internal and external stakeholders.
Coordinate legal requests related to government investigations or litigation.
Ensure quality assurance programs and policies are maintained and updated.
Promote global standardization and facilitate best practice sharing.
QMS Governance & Regulatory Expertise:
Provide interpretation of regulatory requirements (e.g., FDA 21 CFR 820, ISO 13485) and strengthen QMS governance through harmonization across sites and business units.
Audit & Inspection Leadership:
Lead coordination of all internal and external audits and inspections. Drive inspection readiness through structured preparation, risk assessment, and cross-functional alignment. Ensure effective communication, strategy, and execution during audits.
Operations Quality Walk Program:
Manage the Operations Quality Walk program by leading cross-functional teams in routine floor assessments against established criteria. Drive accountability, identify gaps, and ensure timely follow-up and continuous improvement actions.
SAP QM (Quality Management) LDA Support:
Manage SAP QM Local Data Administrator (LDA) activities, including support for material master data, inspection setup, and quality-related system configurations to ensure data integrity and compliance.
Problem Solving & Continuous Improvement:
Apply structured methodologies such as Lean, Six Sigma, and root cause analysis to resolve complex quality issues and improve processes.
Project Leadership & Mentorship:
Lead projects, influence stakeholders, and provide mentorship and guidance to team members and cross-functional partners.
Quality Management Review Support:
Support Quality Management Review (QMR) activities by ensuring accurate data inputs, preparing reports, and facilitating discussions to drive compliance and continuous improvement at the leadership level.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum qualifications are evident on your resume.
Bachelor’s Degree with a minimum of 4 years of relevant experience, or an advanced degree with at least 2 years of relevant experience.
Nice to Have
5+ years of experience with FDA 21 CFR Part 820 and ISO 13485
Lean Six Sigma certification
Lead Auditor certification
Familiarity with Medical Device Single Audit Program (MDSAP)
Experience with TrackWise (Sparta)
Experience with PLM systems such as Agile or Windchill
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.
Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.
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
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.
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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