Careers that Change LivesAt Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. The Quality Systems Specialist is responsible for compliance to Quality System processes including the Corrective and Preventative Action (CAPA) process to Medical Device regulations and requirements serving as a subject matter expert and providing guidance to CAPA owners and working closely with CAPA Board members in the development of CAPA activities and the rigorous assessment of CAPA and quality system documentation.Additionally, you will support internal and external audits during audit preparation and execution. The Structural Heart and Aortic integrated operating unit offer minimally invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta. We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.This position is based in Mounds View, MN within the Structural Heart and Aortic (SHA) operating unit and requires 3 days on-site per week.A Day in the LifeIn general, the following responsibilities apply for the Quality Systems Specialist . This includes, but is not limited to the following:
Provides continuous and rigorous assessment of quality system and CAPA activities and documentation to assure compliance with Medtronic Quality System and CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements through the review of quality system and CAPA records.
Provides guidance, support and mentors CAPA Owners, CAPA Board Members and CAPA Board Chairs regarding the CAPA process, CAPA best practices, CAPA record content, and CAPA software tools.
Provides CAPA and Quality System metrics and reporting on critical aspects regarding the health of the CAPA and Quality System processes.
Participates in CAPA Board activity and performs CAPA Specialist role.
Supports the development and implementation of CAPA and Quality Systems procedures, CAPA and Quality Systems software, and CAPA and Quality Systems training programs.
Supports internal and external audits and inspections for CAPA records and processes.
Participates in audits and inspections in multiple audit support roles in the front and back room.
Performs other related duties as assigned.
MUST HAVE - MINIMUM REQUIREMENTS: To be considered for this role, please be sure the minimum requirements are evident on your resume.
University degree with 2+ years of work experience in Quality, Manufacturing, or advanced degree with 0 years of experience in a regulated industry
Nice to Have
Experience in a regulated environment
Experience working with nonconformances, corrective and preventive actions, and external standards
Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
Experience in audits and inspections
Experience in medical device, pharmaceutical and/or a comparable regulated environment
Influence management skills; ability to work constructively across all functions of the organization as well as external customers
Project management skills
Experience reviewing technical documentation
Strong written and verbal communication skills
Ability to educate people in the CAPA, Audits, and Standards program
Experience with quality tools and process improvement techniques
Strong analytical and decision-making skills
Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements in general and specific to CAPA, Standards and Audits.
About MedtronicTogether, 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.Physical Job RequirementsThe 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. (ADA-United States of America).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. Learn more about our benefits here (https://www3.benefitsolver.com/benefits/BenefitSolverView?pagename=signon&conum=30601&coaffid=medtronic) .This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc. Base pay is based on numerous factors and may vary depending on job-related knowledge, skills, and experience.Min Salary71200Max Salary106800It 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.