Senior Quality Systems Specialist at Medtronic in Fridley, Minnesota

Job Description:

Careers That Change Lives

A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people. Help us engineer the extraordinary!

Join us as we bring the next generation of life-changing medical technology to patients worldwide. We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare.Learn more about Medtronic benefits and compensation at the bottom of this job description.

Medtronic's Neuromodulation/Pelvic Health organization is hiring a Senior Quality Systems Specialist to join their onsite team in Fridley, Minnesota. This will be a hybrid role that will require at least 3 days onsite.

A Day in the Life

In this exciting role, you will have responsibility for working with Corrective and Preventive Actions (CAPA) owners and quality issue/Nonconformance owners across the Neuromodulation/Pelvic Health organization to execute the CAPA process in a compliant and timely manner.

Responsibilities may include but are not limited to:

• Collaborate on 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.
• Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Lead audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
• Prepare reports and/or necessary documentation (i.e., CAPA) and provide to applicable stakeholders, both internal and external.
• Coordinate legal requests in support of government investigations or litigations.
• Ensure the quality assurance programs and policies are maintained and modified regularly.
• Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of company's mission globally.
• Work closely with issue identifiers and owners to assess whether new product or quality system issues will escalate to CAPA investigation.
• Guide CAPA owners through CAPA phases (root cause analysis, action planning and execution, and effectiveness checks) and ensure they follow the CAPA process and deliver solid quality records of their actions.
• Travel: 5% to 10% or less

Must Have: Minimum Qualifications

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile and on your resume.

• Bachelors degree required

• Minimum of 4 years of relevant experience, or advanced degree with 2 years of relevant experience

Nice to Have

• CAPA specialist experience or experience owning CAPA(s)

• Medical device industry experience

• Experience using root cause analysis tools

• Experience writing quality records

• Experience identifying project/timeline risks and taking action to problem-solve or escalate as appropriate

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Benefits & Compensation

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. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). Learn more about MIP and benefits here .

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).

Physical Job Requirements

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.