Associate Quality Systems Specialist

Medtronic plc; Bogotá; On-site; COP 129,592,000 - 194,389,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Job summary

Medtronic plc in Bogotá is seeking a Quality Systems Associate to help develop and maintain quality programs, ensuring compliance with internal policies and external standards. You will support FCA documentation and collaborate across regions to address recalls and FCAs.

The role requires a Bachelor’s degree, fluency in English, and at least 1 year of experience in QMS/Field Action/Recall in the medical device field, plus FCA documentation experience.

Qualifications

• Bachelor's degree is required.
• Fluent in English.
• 1 year of QMS and Field Action/Recall in the Medical Device field.
• 1 year of experience in quality systems.
• 1 year of experience with FCA documentation.

Responsibilities

• Contributes to the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies and that service performance and quality meet established internal and external standards and guidelines.
• Ensure personal understanding of all applicable elements of the Quality Policy/Quality System.
• Follow all quality and work procedures to ensure compliance with the Quality System and the delivery of high-quality work.
• Foster cross-functional collaboration and mutual understanding of product recalls and Field Corrective Actions (FCAs).
• Produces the necessary FCA document packages to be used by Global FCA Coordinator(s) and Region/Country QARA stakeholders.
• Ensure coordination with the Global FCA Coordinator(s) regarding actions to be taken with stakeholders responsible for FCA Planning, Execution, and Closure.
• Resolve issues as necessary to complete daily work activities.
• Provide analytical support for key metrics and operational reporting.
• Maintain all FCA documentation within the appropriate quality system(s).
• Act as a change agent for the organization.
• Identify, facilitate, and implement changes to improve efficiency, ensure compliance, and reduce process complexity as needed.
• Participate in and support Quality System audits within the regions served.
• Operate in environments that comply with Quality System requirements.

Skills

Fluent English

Bachelor's degree

1 year QMS experience

1 year FCA documentation

1 year quality systems

Education

Bachelor's degree

Job description

A Day in the Life

• Contributes to the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies and that service performance and quality meet established internal and external standards and guidelines.


• Ensure personal understanding of all applicable elements of the Quality Policy/Quality System.


• Follow all quality and work procedures to ensure compliance with the Quality System and the delivery of high-quality work.


• Foster cross-functional collaboration and mutual understanding of product recalls and Field Corrective Actions (FCAs).


• Produces the necessary FCA document packages to be used by Global FCA Coordinator(s) and Region/Country QARA stakeholders.


• Ensure coordination with the Global FCA Coordinator(s) regarding actions to be taken with stakeholders responsible for FCA Planning, Execution, and Closure.


• Resolve issues as necessary to complete daily work activities.


• Provide analytical support for key metrics and operational reporting.


• Maintain all FCA documentation within the appropriate quality system(s).


• Act as a change agent for the organization.


• Identify, facilitate, and implement changes to improve efficiency, ensure compliance, and reduce process complexity as needed.


• Participate in and support Quality System audits within the regions served.


• Operate in environments that comply with Quality System requirements.

Required Knowledge and Experience

• Bachelor's degree


• Fluent in English


• 1 year of QMS and Field Action/Recall in the Medical Device field


• 1 year of experience in quality systems


• 1 year of experience with FCA documentation

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.

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 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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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.

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.