Quality System Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.

In this dynamic role as a Quality Systems Specialist you will play a key role in supporting 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.

Job Responsibilities

Responsibilities include the following and other duties may be assigned:

• Support 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.

• Contribute to audit and inspection readiness support all phases of audits resolve findings and serve as liaison with auditors inspectors and internal stakeholders.

• Apply a continuous improvement mindset to enhance quality tools processes and overall system effectiveness.

• Support interpretation of policies regulations and standards to ensure full compliance across the organization.

• 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.

• Communicates and collaborates with internal stakeholders such as Quality R&D Regulatory Operations Service and Repair Supplier Quality Procurement Operations Quality and Program Management Office to effectively maintain the Quality Management System.

• Generates and analyzes standard reports (e.g. Periodic Review External Standards Training and Quality Data Analysis) for compliance with KPIs identification of patterns of underperformance to KPIs.

• Coordinates with Quality System Program Manager on the generation of standard reports for QDA preparation of presentations coordination with data providers and reviewers and processing of records within Agile MAP.

Must Have (Minimum Requirements)

• Bachelors degree with a minimum of 2 years of quality assurance experience in the medical device or pharmaceutical industry OR a Masters degree with 0 prior experience required.

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 FDA regulatory EU MDR and MDSAP requirements.

• Proven experience supporting Corrective and Preventive Actions (CAPA) audits and Change Control Processes.

• Functional experience in root cause investigation including application of root cause analysis tools corrective/preventive action planning execution and verification of effectiveness.

• 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.

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 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 @ 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 .

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 insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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 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 findhere 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.