At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

As a CAPA Quality Systems Specialist you will play a critical role in ensuring compliance with global regulatory requirements while helping to continuously improve our quality system to support innovation and patient safety. This is your opportunity to apply your quality systems expertise in a collaborative environment where your work truly matters.

As a CAPA Quality Systems Specialist you will:

• Lead and support Quality System processes such as CAPA (Corrective and Preventive Action) Internal Audits Management Review and Document Control.

• Serve as a subject matter expert (SME) for one or more Quality System elements in compliance with FDA 21 CFR Part 820 ISO 13485 EU MDR and other global regulations.

• Facilitate and support internal and external audits (e.g. FDA Notified Body ISO) including audit readiness activities evidence preparation and post-audit follow-ups.

• Partner cross-functionally to evaluate improve and harmonize quality system processes and procedures.

• Analyze and interpret quality system data to identify trends and recommend opportunities for improvement.

• Support and mentor junior team members in the interpretation and application of quality system requirements.

• Participate in global projects and initiatives helping to drive standardization and best practices across sites.

Must Have: Minimum Qualifications

• Bachelors Degree and 2 years of relevant experience OR

• Advanced Degree and 0 years of relevant experience

Nice to Have: Preferred Qualifications

• In-depth knowledge of FDA QSR ISO 13485 and EU MDR.

• Strong problem-solving critical thinking and analytical skills.

• Excellent written and verbal communication skills.

• Experience working in a cross-functional matrixed environment.

• ASQ certification (e.g. CQA CQE or CMQ/OE).

• Experience with Audit Management Systems (e.g. TrackWise ETQ).

• Understanding of risk management (ISO 14971) software validation or design control processes.

• Prior experience supporting multiple site operations or global quality systems.

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 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

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 95000 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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.