Associate Quality Systems Specialist

Medtronic plc; Puerto Bogotá; In loco; COP 24.000.000 - 48.000.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary

Flexible benefits package

Descrizione del lavoro

Medtronic plc in Colombia seeks a Quality Assurance professional to develop and maintain QMS and FCA documentation, ensuring compliance with internal and external standards. The role supports audits and cross-functional actions on recalls and FCAs.

The ideal candidate has a Bachelor's degree and at least 1 year in medical device quality systems, with fluent English. A competitive salary and a flexible benefits package accompany the role.

Competenze

• Bachelor's degree in a relevant field.
• 1 year of QMS and FCA in the Medical Device field.
• 1 year of experience with quality systems.
• 1 year of experience with FCA documentation.
• Fluent in English.

Mansioni

• Develop and maintain quality programs, systems, processes to ensure compliance with policies and quality standards.
• Foster cross-functional collaboration on product recalls and FCAs.
• Produce FCA document packages for Global FCA Coordinator(s) and stakeholders.
• Coordinate with FCA Coordinator(s) on actions with FCA planning, execution and closure.
• Support quality system audits and provide analytical metrics.

Conoscenze

Quality systems

FCA documentation

Cross-functional collaboration

Audits

Analytical skills

English fluency

Formazione

Bachelor's degree

Descrizione del lavoro

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.A Day in the LifeResponsibilities may include the following and other duties may be assigned :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 requirementsRequired Knowledge and Experience:Bachelor's degreeFluent in English1 year of QMS and Field Action/Recall in the Medical Device field1 year of experience in quality systems1 year of experience with FCA documentationPhysical Job RequirementsThe 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.Recruitment Fraud AlertWe are aware of phishing scams targeting job seekers. Please keep the following in mind:Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [e-mail] .Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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.