63 Ofertas de Six Sigma en Colombia

The Sr. Associate, Clinical Quality Management, plays a key role in ensuring that quality principles are embedded throughout the lifecycle of clinical studies. This position is responsible for planning, executing, and overseeing quality management activities while safeguarding compliance with internal procedures, applicable regulations, and industry best practices. Through effective coordination, documentation oversight, and regulatory framework maintenance, the Sr. Associate supports the delivery of high-quality clinical outcomes that meet or exceed customer and regulatory expectations, while fostering a culture of continuous improvement across teams.

Responsibilities

• Develop, update, and maintain Quality Plans for assigned clinical studies. Ensure proper follow-up and implementation of quality activities throughout the study lifecycle and align the Quality Plan content with study scope, regulatory requirements, and sponsor expectations.
• Review and monitor the clinical studies Issue Resolution Log to ensure timely resolution and escalation process. Tracks and escalates Clinical Quality Issues as needed. Supports root cause analysis and ensures corrective/preventive measures are documented and implemented.
• Support and, when delegated, lead preparation and execution of external audits and regulatory inspections, ensuring readiness of teams, processes, and documentation. Act as a Quality representative during sponsor audits, regulatory inspections, and compliance assessments (e.g., FDA Bioresearch Monitoring (BIMO) inspections)
• Executes Trial Master File (TMF) audits, identifying gaps and ensuring corrective/preventative actions if required, based on clinical study protocols, good clinical practices, and risk-based audit approach. Perform check-control reviews of essential documents for accuracy, completeness, and compliance.
• Monitors site management trends and escalates risks or recurring issues to leadership.
• Develops and distributes Study Welcome Packages, documentation customized according to clinical study needs, regulations, and scope. Also, leads Quality Management Kick-Off meetings with new sponsors to align quality management systems expectations, and provides ongoing quality guidance to the clinical study teams regarding documentation, compliance, and risk management.
• Collaborates to perform risk management activities within studies, including risk assessments and monitoring risk mitigation effectiveness.
• Collaborates in maintaining and updating the Organizational Regulatory Framework, ensuring alignment with evolving requirements applied to clinical trials (e.g., 21 CFR, ISO, EU MDR). Maintain a current comprehension of all related quality requirements and communicate changes effectively according to established QMS procedures and updated training materials.
• Monitor customer feedback and complaints to identify opportunities for improvement. Implement measures to enhance customer satisfaction through improved product quality and service.
• Support the management of Zelery, Subsidiaries and Affiliates, Policies, SOPs, work instructions, forms, etc. Distribute SOPs for review and approval. Coordinate the approval of SOPs and maintenance of associated documents.
• Other duties as assigned or required.

Qualifications

• Bachelor's degree in Life Sciences (Biomedical Engineering, Pharmacy, Nursing, or related field)
• At least 5 years of experience in clinical quality management, clinical operations, or regulatory compliance within a CRO, sponsor, or MedTech environment.
• Experience with ICH GCP, ISO 14155, 21 CFR, and regional regulatory frameworks.
• Hands-on experience with TMF management, audits, and risk-based quality approaches strongly preferred.
• Demonstrates attention to detail and organizational skills, discretion with confidential information, solid time management skills, is proactive, and displays a professional demeanor with a high focus on compliance and responsibilities.
• Strong interpersonal skills and ability to work as an effective team member and with cross-functional groups.
• Excellent English verbal and written communication skills. Ability to read and interpret documents such as regulations, SOPs, standards, study protocols, medical terminology, technical dossiers, and other clinical study documentation.

We never ask for payment as part of our selection process, and we always contact candidates via our corporate accounts and platforms. If you are approached for payment, this is likely to be fraudulent. Please check to see whether the role you are interested in is posted on our career website.

Role Purpose

The Continuous Improvement (CI) Manager – Black Belt plays a pivotal role in driving operational excellence across TMF Group by leading Lean Six Sigma (LSS) initiatives, coaching belt candidates, and embedding a culture of continuous improvement. This role is responsible for mentoring LSS candidates, facilitating training, and ensuring the successful execution of improvement projects that align with TMF's strategic goals.

Key Responsibilities

Establish a continuous improvement methodology and approach for TMF Group

• Train Operational Excellence staff to become black belts, green belts and yellow belts
• Deliver Lean Six Sigma training to client delivery teams, to build continuous improvement across our teams

Lean Six Sigma Program Leadership

· Lead and facilitate LSS training programs across TMF.

· Coach and mentor lean coaches candidates through their certification journeys, including project selection, charter development, and execution

· Promote group-based project collaboration and ensure alignment with TMF's global CI strategy

Program Coordination and Reporting

· Coordinate recurring forums such as Lean Forum – East/West to track progress and share best practices

· Maintain dashboards and reporting tools to monitor training completion, certification status, and project outcomes

· Collaborate with global and regional CI leaders to align initiatives and share insights

Key Competencies

· Deep expertise in Lean Six Sigma methodologies (Black Belt certified or equivalent).

· Strong coaching and facilitation skills, with the ability to guide without micromanaging.

· Excellent communication and interpersonal skills across cultures and time zones.

· Analytical mindset with the ability to define and track success metrics.

· Proficiency in using digital tools for collaboration, reporting, and knowledge sharing.

Background

8+ years of experience driving continuous improvement at scale

Black Belt, with accreditations to deliver certified training to others

Experience in leading continuous improvement within a global, professional services and/or financial services firm

Firm Mission Statement

Our mission is to change as many lives as possible by offering immigration solutions even in the most difficult cases. We look at all possible options to keep our clients in the United States with their families where they belong. We stand ready to fight even when success seems unsure because we understand how much better life can be with the dignity and peace of mind that comes with having documents.

Position Overview

The Process Improvement Team Lead oversees a diverse team of Project Managers, Process Engineers, and Process Improvement Specialists that are responsible for leading and executing process creation and process improvement projects from initiation to completion. This role involves supporting and providing guidance on different process improvement and project management methodologies, ensuring they align with organizational goals and project management principles. This individual must have a proven track record of success in leading a variety of process creation and improvement projects with an emphasis on lean, six sigma, PDCA, DMAIC, waterfall, and agile methods with a strong emphasis on time management. This role must have the ability to lead and advise their team by providing training, guidance, and performance management. Additionally, the candidate should be efficient at managing resources and effective at communicating with diverse teams and stakeholders.

Essential Job Functions & Responsibilities

1. Supervise and mentor a diverse team of Project Managers, Process Engineers, and Process Improvement Specialists by providing guidance, support, performance management, and payroll to ensure high levels of productivity and morale.
2. Ensure team members are utilizing lean and project management principles in all project work including project charters, data collection and risk management tools, and change management processes.
3. Oversee and support team member’s lean training and development.
4. Ensure that all projects are executed and delivered on time, within scope, and within budget by monitoring progress, managing resources, and assisting with removal of any roadblocks.
5. Facilitate team meetings and 1:1’s to review questions and any process updates.
6. Oversee and ensure that all project deliverables meet the quality standards and expectations set by the Firm and the project sponsor.
7. Supervise team members to ensure they are providing regular and consistent reports and updates on project progress, status, risks, and other necessary information.
8. Serve as the primary point of escalation for assisting with highly complex or unique projects.
9. Assist with addressing and resolving any conflicts or issues within project teams or with stakeholders.
10. Identify opportunities to improve project management processes and implement best practices to enhance overall efficiency.

Firm Mission Statement

Our mission is to change as many lives as possible by offering immigration solutions even in the most difficult cases. We look at all possible options to keep our clients in the United States with their families where they belong. We stand ready to fight even when success seems unsure because we understand how much better life can be with the dignity and peace of mind that comes with having documents.

Position Overview

The Process Improvement Team Lead oversees a diverse team of Project Managers, Process Engineers, and Process Improvement Specialists that are responsible for leading and executing process creation and process improvement projects from initiation to completion. This role involves supporting and providing guidance on different process improvement and project management methodologies, ensuring they align with organizational goals and project management principles. This individual must have a proven track record of success in leading a variety of process creation and improvement projects with an emphasis on lean, six sigma, PDCA, DMAIC, waterfall, and agile methods with a strong emphasis on time management. This role must have the ability to lead and advise their team by providing training, guidance, and performance management. Additionally, the candidate should be efficient at managing resources and effective at communicating with diverse teams and stakeholders.

Essential Job Functions & Responsibilities

1. Supervise and mentor a diverse team of Project Managers, Process Engineers, and Process Improvement Specialists by providing guidance, support, performance management, and payroll to ensure high levels of productivity and morale.
2. Ensure team members are utilizing lean and project management principles in all project work including project charters, data collection and risk management tools, and change management processes.
3. Oversee and support team member’s lean training and development.
4. Ensure that all projects are executed and delivered on time, within scope, and within budget by monitoring progress, managing resources, and assisting with removal of any roadblocks.
5. Facilitate team meetings and 1:1’s to review questions and any process updates.
6. Oversee and ensure that all project deliverables meet the quality standards and expectations set by the Firm and the project sponsor.
7. Supervise team members to ensure they are providing regular and consistent reports and updates on project progress, status, risks, and other necessary information.
8. Serve as the primary point of escalation for assisting with highly complex or unique projects.
9. Assist with addressing and resolving any conflicts or issues within project teams or with stakeholders.
10. Identify opportunities to improve project management processes and implement best practices to enhance overall efficiency.

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
The Business Analyst supports the global Service and Repair team by delivering critical analytical insights, resolving operational challenges, and driving continuous process improvement. This role liaises with cross-functional teams—including IT, supply chain, finance, and master data to troubleshoot workflow and system issues, coordinate enhancements, and ensure data integrity.

The Business Analyst contributes to the following activities within the global Service and Repair team (S&R):

• Provide day-to-day analytical and problem-solving support to business operations by investigating and resolving issues related to system processes, workflows and data anomalies.
• Liaise with cross-functional teams (such as IT, S&R business operations, master data, supply chain, finance etc.) to identify root causes of operational issues and recommend actionable solutions or system enhancements.
• Connect and collaborate with IT partners for process and system improvements. Proactive monitoring, maintaining and govern Service and Repair master data ensuring accuracy, consistency and compliance.
• Support and execute Business Analyst activities in coordinating and driving Analytics, Insights and Reporting implementations, including user acceptance testing in close collaboration with key users.
• Monitor key performance indicators (KPI's) and system-generated reports to proactively identify trends or inefficiencies in business processes and support the continuous improvement initiatives.
• Execute against product vision and commitments in an Agile environment.
• Perform large scale data & systems analysis.
• Manage and 'own' significant pieces of project deliverables end-to-end from the initial demand, all the way to testing the agreed solution and delivering to production.
• Be able to understand complex requirements, come up with high quality solutions to address the demand and fully explore dependencies and implications on various components of introducing the change.
• Survey, analyze and evaluate processes, products and services.
• Conduct requirements gathering activities, using a variety of internal and external data and conducting end stakeholder interviews.
• Act as a linking pin between the business, Material Master Data management and IT (Service & Repair) and being involved in topics on strategic architecture and design. Provide documentation of processes and business requirements.
• Take on project management tasks and services.

Qualifications

• Bachelor's degree.
• At least 5 years of experience as a (Sr.) Business Analyst
• Strong analytical, problem-solving, and synthesizing skills with the ability to work independently, with guidance provided as needed.
• The ability to interpret a set of business and technical requirements and contribute to developing robust solutions.
• Strong communication and influencing skills, with ability to communicate effectively with business and IT stakeholders.
• Flexible and resilient team player with strong interpersonal skills taking initiative to drive things forward.
• Adaptable, able to work across teams and functions in a multinational environment.
• Experience with SAP (Preferably MDM and or CS)
• Professional proficiency in English including written and verbal communication.

Nice to Have

• Prior experience with SCRUM/Agile methodologies.
• Business analysis or project management experience in the medical device industry, ideally with a background in Service & Repair.
• High proficiency with Excel Spreadsheets, Business Objects, and SAP, experience creating Excel documents, including spreadsheets, formulas, charts, graphs, and functions.
• Eager to grow and develop their knowledge and skills.
• Servant leadership perspective to support and enable the business stakeholders.
• Global mindset and willingness to learn.
• Professional proficiency in English including written and verbal communication.
• Affinity with emerging technologies like (gen) AI.

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 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

Overview

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 We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.

This position focuses on leading process improvement initiatives—such as Lean or Six Sigma—by analyzing and redesigning workflows, measuring performance, and identifying opportunities for operational efficiency and quality enhancement. It involves managing cross-functional teams, developing metrics, conducting root cause analyses, and aligning improvements with organizational goals. As a program manager, the role oversees tactical execution of mature programs, ensures stakeholder alignment, and drives results through influence rather than direct authority. It requires advanced knowledge in programming and process management and strong communication skills. This position will be a Hybrid position in Bogotá.

• Lead Process Improvement Initiatives: Plan, execute, and monitor Lean, Six Sigma, or similar methodologies to enhance operational efficiency and product quality
• Analyze and Redesign Processes: Diagram, evaluate, and optimize existing workflows to align with commercial and organizational goals
• Facilitate Cross-Functional Collaboration: Organize and lead project teams across departments to drive process improvements and resolve performance gaps
• Develop and Track Metrics: Create performance indicators and collect data to measure outcomes, identify root causes, and guide future improvements
• Engage with Commercial Teams: Maintain ongoing communication with the Commercial team to understand, prioritize, and address their needs and challenges
• Participate in Commercial Meetings: Attend and report updates in commercial forums to identify improvement opportunities aligned with Cluster Priorities
• Map and Align Processes Across Functions: Collaborate with various departments to document processes, align stakeholders, and propose enhancements that support commercial strategies
• Provide Expert Consultation and Training: Offer guidance on re-engineering techniques and deliver training on measurement, analysis, and control methods
• Conduct Benchmarking and Cost-Benefit Analysis: Research best practices and perform financial evaluations to support decision-making
• Communicate Progress and Influence Stakeholders: Share updates with internal and external partners, and influence outcomes through collaboration rather than direct authority

• Bachelor’s degree in business administration, Industrial Engineering, Marketing, or related field. A master’s degree or MBA is a plus
• Minimum of 5 years of relevant experience, or 3 years with an advanced degree
• Intermediate – Fluent in English
• Familiarity with Lean, Six Sigma, or similar frameworks

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.

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).

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.

Business Process Improvement Program Manager

Medtronic Bogota, D.C., Capital District, Colombia

Hybrid position in Bogotá.

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 position focuses on leading process improvement initiatives—such as Lean or Six Sigma—by analyzing and redesigning workflows, measuring performance, and identifying opportunities for operational efficiency and quality enhancement. It involves managing cross-functional teams, developing metrics, conducting root cause analyses, and aligning improvements with organizational goals. The program manager oversees tactical execution of mature programs, ensures stakeholder alignment, and drives results through influence rather than direct authority. This position will be hybrid in Bogotá.

• Lead Process Improvement Initiatives: Plan, execute, and monitor Lean, Six Sigma, or similar methodologies to enhance operational efficiency and product quality
• Analyze and Redesign Processes: Diagram, evaluate, and optimize existing workflows to align with commercial and organizational goals
• Facilitate Cross-Functional Collaboration: Organize and lead project teams across departments to drive process improvements and resolve performance gaps
• Develop and Track Metrics: Create performance indicators and collect data to measure outcomes, identify root causes, and guide future improvements
• Engage with Commercial Teams: Maintain ongoing communication with the Commercial team to understand, prioritize, and address their needs and challenges
• Participate in Commercial Meetings: Attend and report updates in commercial forums to identify improvement opportunities aligned with Cluster Priorities
• Map and Align Processes Across Functions: Collaborate with various departments to document processes, align stakeholders, and propose enhancements that support commercial strategies
• Provide Expert Consultation and Training: Offer guidance on re-engineering techniques and deliver training on measurement, analysis, and control methods
• Conduct Benchmarking and Cost-Benefit Analysis: Research best practices and perform financial evaluations to support decision-making
• Communicate Progress and Influence Stakeholders: Share updates with internal and external partners, and influence outcomes through collaboration rather than direct authority

• Bachelor’s degree in business administration, Industrial Engineering, Marketing, or related field. A master’s degree or MBA is a plus
• Minimum of 5 years of relevant experience, or 3 years with an advanced degree
• Intermediate – Fluent in English
• Familiarity with Lean, Six Sigma, or similar frameworks

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.

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).

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.

Learn more about our business, mission, and our commitment to diversity here.