Senior Quality Systems Specialist - Tempe

We anticipate the application window for this opening will close on - 5 Mar 2026 · 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 innov ...

Job description

We anticipate the application window for this opening will close on - 5 Mar 2026

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

Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That's the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.

Onsite- 100%

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work.

We're working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

In this exciting role as a Senior Quality Systems Specialist, supporting the Tempe Campus, you will have responsibility for leading the coordination of FDA inspections and ISO 13485 audits, serving as the primary liaison between auditors and site leadership, and driving robust audit preparedness.

You will also play a key role in strengthening Quality Management System (QMS) governance by interpreting regulatory requirements, harmonizing site procedures, and ensuring consistent, compliant operations across the organization.

Senior Quality Systems Specialist


Location:
Tempe, AZ


A Day in the Life:

As a Quality Systems leader, you will play a key role in driving site compliance, continuous improvement, and cross-functional leadership.

Your day is dynamic and impactful, encompassing:
Responsibilities may include the following and other duties may be assigned.

Key Responsibilities

Oversee the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with company policies and regulatory standards.

Provide expertise and guidance in interpreting internal and external regulations to ensure ongoing compliance.
Collaborate with operating entities to enforce requirements and ensure regulatory adherence.

Lead audit and inspection preparation, manage resolution of findings, and liaise with auditing groups and inspectors throughout all audit stages.

Prepare reports and required documentation (e.g., Corrective and Preventative Actions) for internal and external stakeholders.
Coordinate legal requests in support of government investigations or litigation.
Ensure quality assurance programs and policies are regularly maintained and updated.
Promote the implementation of uniform standards worldwide and facilitate best practice sharing to support the company's global mission.

QMS Governance & Regulatory Expertise:
Provide advanced interpretation of FDA 21 CFR 820 and ISO 13485 requirements to ensure robust site-level compliance. Strengthen QMS governance by harmonizing procedures across the site, Operating Units, and the enterprise.

Audit & Inspection Leadership:

Lead end-to-end coordination of FDA inspections and ISO 13485 audits, managing all aspects of front room, back room, and strategy room operations.

Serve as the primary liaison between auditors/inspectors and site leadership, ensuring consistent messaging, risk-based response strategies, and controlled documentation flow.

Drive inspection preparedness through pre-audit risk assessments, gap analyses, and mock audits. Translate audit findings into actionable systemic improvements and governance enhancements.

Quality Systems Transformation & Harmonization:
Lead and support quality systems improvement initiatives. Partner with stakeholders to modernize procedures, enhance documentation architecture, and reduce systemic compliance risk.

Risk Assessment & Knowledge Management:
Conduct structured risk assessments on audit trends, inspectional observations, and systemic vulnerabilities. Facilitate post-audit knowledge sharing and integrate audit intelligence into proactive quality improvement initiatives.

Problem Solving & Continuous Improvement:

Apply structured methodologies (DMAIC, Lean Six Sigma, Cause Mapping, and other root cause analysis tools) to address complex quality system issues.

Lead cross-functional teams to resolve challenging compliance issues and drive measurable process improvements.

Project Leadership & Mentorship:
Lead small- to medium-scale projects with competing priorities and tight timelines. Influence senior stakeholders and cross-functional partners to achieve aligned compliance outcomes. Provide mentorship and technical guidance to quality professionals and project contributors.


Must Have:
Minimum Requirements

To be considered for this role, please ensure the minimum qualifications are evident on your resume.

Bachelor's Degree and a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Nice to Have

Preferably 5+ years of 21 CFR Part 820 and ISO 13485 experience
Lean Six Sigma Certification
Lead Auditor Certification
Familiarity with Medical Device Single Audit Program (MDSAP)
Experience with TrackWise (Sparta)
Experience with Project Life Cycle Management (PLM) systems such as Agile or Windchill

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):
$89, $134,400.00

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:
About Medtronic

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.