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Configuration Assurance Administrator- Change Analyst

Configuration Assurance Administrator- Change Analyst

Medtronic PlcTempe, AZ, US
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Configuration Assurance Administrator Change Analyst

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.

This role will require 0% travel to enhance collaboration and ensure successful completion of projects. In this dynamic opportunity as a Change Analyst supporting our Tempe Campus, you'll take the lead in managing all aspects of the Configuration Management function for local non-Quality Management System documents and records. You'll drive operational excellence by achieving ambitious lead time reduction targets while maintaining First Pass Quality metrics exceeding 85%.

As a Change Analyst, you will :

  • Process change orders, ranging from simple-to-complex, for the creation and revision of product, process, and system designs.
  • Review and analyze change data provided by all functions and facilitate coordination of changes with applicable stakeholders, including engineering, quality, manufacturing, operations, and regulatory.
  • Manage the change order process and prepare for change approvals by stakeholders.
  • Prepare change management status reports.
  • Ensure customer requirements are implemented while maintaining compliance with applicable policies, procedures, regulations, and standards.
  • Functional skills : Change Control, Document Management, Compliance, Product Lifecycle Management, Electronic Document Management Systems, Enterprise Resource Planning (ERP) Systems.
  • Additional skills : Problem Solving, Detail Oriented, Cross-Functional Collaboration, Customer Service, Process Improvement, Communication.

Let this role be your chance to contribute to life-saving innovations while shaping the future of healthcare. Are you ready to lead with purpose and make a difference?

Must have : Minimum Requirements

  • Requires 4+ years of experience in document control / quality management system (QMS) with a High School Diploma or equivalent or Advanced Degree with a minimum of 2 years relevant experience in document control / quality management system.
  • May have practical knowledge of project management.
  • HS diploma or equivalent required.
  • Nice to Have (Preferred Qualifications)

  • Experience working with Agile, Windchill or other Program Lifecycle Management systems.
  • Experience in medical devices, pharmaceutical and / or a comparable regulated environment.
  • Strong analytical, process improvement, critical thinking, and decision-making skills.
  • Ability to educate people in the Change Control process.
  • Influence management skills; ability to work constructively across all functions of the organization as well as external customers.
  • Strong written and verbal communication skills.
  • Understanding of FDA regulations (21 CFR 820, 210 / 211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements.
  • 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.

    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.

    Salary ranges for U.S (excl. PR) locations (USD) : $67,200.00 - $100,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). 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).

    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

    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 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.

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    Configuration Analyst • Tempe, AZ, US