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Senior Quality Systems Specialist - CST - Fort…
- Medtronic (Fort Worth, TX)
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We anticipate the application window for this opening will close on - 24 Oct 2025
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
Medtronic’s Cranial and Spinal Technologies (CST) Operating Unit is committed to transforming patient care through groundbreaking innovations in neurosurgery and spinal procedures. Our comprehensive portfolio includes spinal implants, robotics-assisted surgical solutions like the Mazor™ Robotic Guidance System, StealthStation™ surgical navigation, and biologics for bone healing, all designed to enhance surgical precision, efficiency, and patient outcomes. Beyond technology, we support surgeons through education, training, and clinical research, ensuring they have the tools and knowledge to achieve the best possible results. By continuously driving innovation and collaboration, Medtronic is redefining cranial and spinal care, improving lives worldwide.
Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
\#Neuroscience
Careers That Change Lives
In this dynamic role as a Senior Quality System Specialist, you will play a key role in overseeing the development, implementation, and maintenance of quality systems, programs, processes, and procedures that ensure compliance with company policies and regulatory standards. You will work both independently and collaboratively across teams and functions to uphold the highest standards of quality and performance.
Responsibilities may include the following and other duties may be assigned.
+ Lead the Corrective and Preventive Actions (CAPA) Program, including root cause investigations, application of analysis tools, action planning, execution, and verification of effectiveness.
+ Prepare and deliver communications, reports, and documentation related to CAPA activities to internal and external stakeholders.
+ Drive audit and inspection readiness—manage all phases of audits, resolve findings, and serve as the primary liaison with auditors and inspectors.
+ Apply a continuous improvement mindset to enhance quality tools, processes, and overall system effectiveness.
+ Provide expert interpretation of policies, regulations, and standards to ensure full compliance across the organization.
+ Partner with operational teams to deliver ongoing process analysis and compliance oversight.
+ Coordinate responses to legal or regulatory requests, including those supporting investigations or litigation.
+ Maintain and update quality assurance programs and policies to reflect evolving standards and best practices.
+ Promote consistency and best-practice sharing across global operations, advancing the company’s mission and quality excellence worldwide.
**Location** : Fort Worth, TX
+ _This is an onsite position located in Fort Worth, Texas._
**Ability to travel up to** : N/A
Must Have (Minimum Requirements)
To be considered for this role, please ensure the minimum requirements are evident on your resume** **.
+ Bachelor’s degree required with a minimum of 4 years of Quality tools and Process Improvement experience
+ OR advance degree with a minimum of 2 years of Quality tools and Process Improvement experience
Nice to Have (** **Preferred Qualifications** **)
+ Demonstrated continuous improvement mindset with hands-on experience using quality tools and process improvement methodologies.
+ Strong working knowledge of Quality Management Systems (QMS) compliant with ISO 13485 standards.
+ Familiarity with Quality Management System Regulation (QMSR) and applicable FDA regulatory requirements.
+ Basic understanding of EU MDR and MDSAP requirements.
+ Proven experience managing Corrective and Preventive Actions (CAPA), audits, and Change Control Processes.
+ Functional expertise in root cause investigation, including application of root cause analysis tools, corrective/preventive action planning, execution, and verification of effectiveness.
+ Experience in quality and compliance auditing; Auditor or Lead Auditor certifications preferred (e.g., ASQ CQA, ASQ CMDA, Exemplar Global, AAMI).
+ Proficiency with TrackWise and Agile PLM systems.
+ Familiarity with change management frameworks and document control processes.
+ Excellent communication (verbal and written), critical thinking, interpersonal, organizational, time management, and presentation skills.
+ Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
+ Ability to work independently and collaboratively within teams and across functions.
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):$89,600.00 - $134,400.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=medtronic)
About Medtronic
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 (http://www.medtronic.com) .
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 (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) 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.
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.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will…
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
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.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email [email protected]
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