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Assoc Quality Application Specialist

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.

A Day in the Life

In this exciting role as an Associate Quality Application Specialist, you will support Synergy Business as a member of the Internal Supplier Quality Organization for the West Platform. The role is both dynamic and demanding. Internal Supplier Quality plays a vital service-oriented role that impacts and collaborates with various departments across the site, including Finance, Manufacturing, Compliance, and Supply Chain. Quality operations support these areas in multiple ways.

Responsibilities may include the following and other duties may be assigned.

  • Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
  • Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
  • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
  • Reports on the status of validation activities to fulfill regulatory requirements.
  • Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
  • Support incoming inspections for potential components rejections, evaluating rejected materials to determine their usage and disposition, and maintaining KPI metrics.
  • Performs system administration and configuration of quality information technology systems.

Must Have: Minimum Requirements

  • Bachelor degree required
  • 0 years of experience

Nice to Have

  • Knowledge in SAP QM Module
  • Knowledge in Trackwise Systems
  • Knowledge in Agile system and FactoryWorks system
  • Bilingual (English and Spanish)

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.
 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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 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 here 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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Average salary estimate

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What You Should Know About Assoc Quality Application Specialist, Medtronic

Join Medtronic as an Associate Quality Application Specialist located in Juncos, Puerto Rico and embark on a fulfilling career that's dedicated to exploring healthcare innovation and improving access for everyone. In this dynamic role, you'll work closely with the Synergy Business, becoming a key player in our Internal Supplier Quality Organization for the West Platform. You're not just filling a position; you're joining a passionate team that collaborates across various departments like Finance, Manufacturing, Compliance, and Supply Chain to drive quality operations. Your responsibilities will span from conducting compliant validation processes for quality IT systems, which involves formal documentation under federal standards, to liaising with clients and programmers to ensure quality standards are met globally. Moreover, you’ll be proactive in identifying compliance requirements and will be responsible for reporting on validation activities, ensuring that we stay ahead of evolving federal and international regulations. Got a flair for troubleshooting? You'll support incoming inspections, assess rejected materials, and maintain key performance indicators. With a bachelor’s degree and a can-do attitude, this role might just be your next big adventure! Additional knowledge of SAP QM Module and systems like Trackwise or FactoryWorks would truly be a bonus in your journey with us. At Medtronic, we are all about innovation, acceptance, and diversity, and we can’t wait to see how you'll contribute to our mission to alleviate pain and restore health for countless individuals.

Frequently Asked Questions (FAQs) for Assoc Quality Application Specialist Role at Medtronic
What are the main responsibilities of an Associate Quality Application Specialist at Medtronic?

As an Associate Quality Application Specialist at Medtronic, your primary responsibilities will include conducting compliant validation processes for quality information technology systems, coordinating with clients and programmers to meet compliance standards, and reporting on validation activities to fulfill regulatory requirements. You'll also support inspection processes for materials and maintain essential key performance indicators to ensure quality standards are upheld.

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What qualifications are needed for the Associate Quality Application Specialist position at Medtronic?

To qualify for the Associate Quality Application Specialist role at Medtronic, you need a Bachelor’s degree. While prior experience is not mandatory, familiarity with quality assurance processes, SAP QM Module, or systems like Trackwise and FactoryWorks will enhance your application. Bilingual skills in English and Spanish are also an asset as they facilitate communication in our diverse work environment.

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How does Medtronic support the success of its Associate Quality Application Specialists?

Medtronic is committed to the success of its Associate Quality Application Specialists by offering a competitive salary, flexible benefits package, and a supportive work culture that values contributions from all employees. Additionally, we provide numerous resources aimed at professional development which bolster your skills and foster a spirit of innovation and collaboration within the team.

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What is the working environment like for an Associate Quality Application Specialist at Medtronic?

The working environment for an Associate Quality Application Specialist at Medtronic is vibrant and collaborative. You will work alongside a diverse team that is dedicated to innovation and quality healthcare solutions. Your role will involve regular interaction with various departments, making dynamic teamwork an essential part of your daily experience in creating effective solutions.

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What ongoing training and development opportunities does Medtronic offer for this position?

Medtronic offers a robust training and development program for Associate Quality Application Specialists. You will have access to tools that help you keep abreast of changing regulatory requirements and advances in technology. Continuous learning is part of our ethos as we strive to create cutting-edge healthcare solutions.

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Common Interview Questions for Assoc Quality Application Specialist
Can you describe your experience with quality validation processes?

When answering this question, emphasize any academic projects or internships that involved quality validation or compliance processes. Discuss specific methods or tools you've learned, and how you would adapt those experiences to the Associate Quality Application Specialist role at Medtronic.

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How do you stay informed about changing regulatory requirements?

Demonstrate your commitment to professional development by mentioning relevant websites, organizations, or newsletters you follow. Explain how you plan to maintain this knowledge as an Associate Quality Application Specialist at Medtronic, and how it relates to ensuring compliance.

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What quality assurance tools or software are you familiar with?

List any tools you're familiar with, such as SAP QM Module or Trackwise. If you're not experienced with them, express your willingness to learn and adapt quickly, and highlight any related software knowledge you have that could be transferable to the Associate Quality Application Specialist role.

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Describe a time you had to work with a diverse team.

Share a specific instance that showcases your ability to work collaboratively in a diverse environment. Highlight your teamwork skills and sensitivity towards different perspectives, as this is crucial for the Associate Quality Application Specialist role at Medtronic.

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How do you prioritize your tasks when facing tight deadlines?

Provide an example of a time you effectively managed competing priorities. Discuss your approach to organizing tasks and how this strategy could be applied as an Associate Quality Application Specialist at Medtronic.

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What would you do if you discovered a compliance issue?

Illustrate your problem-solving skills by outlining the steps you would take to address the compliance issue. Emphasize your accountability and quality assurance mindset, which are critical components of the Associate Quality Application Specialist position.

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Can you explain the importance of KPIs in quality assurance?

Discuss how KPIs are essential in measuring success and compliance in quality assurance. Relate this to the role of Associate Quality Application Specialist at Medtronic by providing specific examples of KPIs you believe are important for the industry.

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Describe your experience with documentation in a regulated environment.

Mention any relevant coursework or previous job experiences that required meticulous documentation. Show how your attention to detail contributes to compliance, which is vital for the Associate Quality Application Specialist role at Medtronic.

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How do you approach learning new systems or technologies?

Share your methodology for learning new software or processes, such as utilizing training resources or hands-on practice. Highlight your enthusiasm for continuous learning, especially with tools relevant to the Associate Quality Application Specialist position.

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Why do you want to work at Medtronic?

Express your genuine admiration for Medtronic's mission to alleviate pain and restore health. Share how your values align with the company's goals and how this inspires you to contribute as an Associate Quality Application Specialist.

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Mission Written in 1960, our Mission dictates that our first and foremost priority is to contribute to human welfare. Over a half-century later, the Mission continues to serve as our ethical framework and inspirational goal for our employees aroun...

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