Quality Systems Specialist
Medtronic
Office
CA Northridge, United States
Full Time
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 is a world leader in providing health care products that restore health and extend life. The Medtronic Diabetes R&D team contributes directly to this mission; we deliver software and firmware for Medtronic’s pump and continuous glucose monitoring devices.Our business is growing significantly as the market demands reliable medical devices which look and feel more like consumer devices. We are looking for an Associate Quality Systems Specialist who can help us continue to make devices more robust and reliable for our patients.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Engineers create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide. This is a unique opportunity to apply your best technical innovation, problem solving and leadership skills to improving how people live their lives every day.
Minimum Requirements:
Requires a Baccalaureate degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
NICE TO HAVE:
- Intermediate or better level of experience with Microsoft suite, including but not limited to Word, Excel, SharePoint, Teams, PowerPoint and Adobe
- Experience with Oracle Agile, Trackwise and/or PowerBI systems
- Experience in FDA, Certifying Body and/or Notified Body audits/inspections
- Experience or training in project management
- Experience with medical device industry Regulations, Standards and Quality Management Systems
Other Responsibilities:
- Supports the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Conduct quality reviews of Change Orders for Quality Management System documents and records.
- Provides expertise and guidance to stakeholders in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Supports audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Prepares reports and/or necessary documentation, data analysis, etc. and provides to applicable stakeholders.
- Co-ordinates implementation of enterprise changes within local quality management system.
- Co-ordinates legal requests in support of government investigations or litigations.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
- Leads smaller quality projects and project teams, while facilitating larger quality projects in a variety of roles
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages tasks or project actions assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals
DIFFERENTIATING FACTORS
Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments
Innovation and Complexity:
- Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
- Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area
Communication and Influence:
- Communicates primarily and frequently with internal contacts.
- Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Superior internal customer service is a must
Leadership and Talent Management:
- May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream
- U.S. Pay Transparency (for SIP, Commission, Hourly Direct, Interns, Executives)
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.
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
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.
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.
Quality Systems Specialist
Office
CA Northridge, United States
Full Time
August 18, 2025