- Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Prepares reports and/or necessary documentation (ex-Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
- Co-ordinates legal requests in support of government investigations or litigations.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
- Fluent in English level
- Fluent in Portuguese.
- High degree of organization and prioritization skills
- Ability to work in a fast-paced environment with high attention to detail and follow through
- Strong relationship building, communication and interpersonal skills.
- Proactive and good customer service skills
- Team player
- Strong critical thinking and analytical skills
- Strong project management and critical thinking skills
- Medical Device Industry experience
- Knowledge with MS office (Outlook, Word, Excel, PowerPoint, etc.)
- Previous experience supporting quality system audits.
- Strong technical writing and documentation review skills
- Independent compliance decision maker (based on knowledge of regulations, available relevant information, alternatives, risk)
- Good understanding of the Medical Device Regulations and the Food and Drugs Acts as pertinent to the position, working knowledge of ISO 13485, and Medtronic policies and procedures.
- Technologist degree related to pharmacy.
-
System Sales Specialist
hace 3 semanas
Signify Bogota, ColombiaJob Title · System Sales Specialist (Bogotá, Colombia) · **Job Description**: · We're looking for a System Sales Specialist - Office & Industry to join our System & Services team in Colombia. · Working for Signify means being creative and adaptive. Our culture of continuous learn ...
-
Quality Systems Specialist
hace 3 semanas
Medtronic Bogota, Colombia**Careers that Change Lives · **A Day in the Life**: · - Execution of Complaint Handling activities: Regulatory decisions and regulatory reporting (drafting and submission). · - Execute tasks using Complaint Handling tools/systems (Global Complaint Handling system). · - Ensure cl ...
-
HR Systems Specialist
hace 3 semanas
UNITED PARCEL SERVICE Bogota, ColombiaExplore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow—people with a unique combin ...
-
Quality Systems Specialist
hace 3 semanas
Medtronic Bogota, Colombia**Careers that Change Lives** · **A Day in the Life** · Responsibilities may include the following and other duties may be assigned. · - Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with polic ...
-
IT Quality Systems Specialist
hace 10 horas
Medtronic Bogota, Colombia**Careers that Change Lives** · We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. · Bring your talents to an in ...
-
IT Quality Systems Specialist
hace 1 semana
Medtronic Bogota, Colombia**Careers that Change Lives** · This position requires the ability to support the Medtronic IT systems validations, maintenance, strategies and accurate review of specific documentation as required by the IT quality processes. The position requires the understanding of auditing a ...
-
Manufacturing Systems Support Specialist
hace 3 semanas
Zimmer Biomet Bogota, Colombia**Requisition Number**: AMER28043 · **Employment Type**: Full-time · **Location**: Bogota · **Job Summary**: This specialist will support the configuration of the Manufacturing Execution System (MES) and other associated process control systems for new product introductions and e ...
-
Senior Quality Systems Specialist
hace 3 semanas
Medtronic Bogota, Colombia**Careers that Change Lives** · Support Latin America Region Post Market Vigilance activities related to Field Corrective Action (FCA). · **A Day in the Life** · Responsibilities may include the following and other duties may be assigned. · - Support implementation and compliance ...
-
Associate Quality Systems Specialist
hace 2 semanas
Medtronic Bogota, Colombia**Careers that Change Lives** · 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 pa ...
-
Quality Management Systems Specialist
hace 1 semana
Zimmer Biomet Bogota, Colombia**Requisition Number**: AMER28362 · **Employment Type**: Full-time · **Location**: Bogota · **Job Summary**: This is an experienced level position in Quality Management Systems (QMS). This position requires an understanding of applicable global regulations. The Corporate QMS Spec ...
-
Quality Management Systems Sr Specialist
hace 2 semanas
Zimmer Biomet Bogota, ColombiaAt Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. · As a Zimmer Biomet team m ...
-
IT Quality Systems Specialist
hace 3 semanas
Medtronic Bogotá, ColombiaCareers that Change Lives We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. · Bring your talents to an industr ...
-
Italian Speaker Quality Systems Specialist
hace 3 semanas
Medtronic Bogotá, ColombiaCareers that Change Lives · 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 ...
-
German Speaker Quality Systems Specialist
hace 2 semanas
Medtronic Bogotá, ColombiaCareers that Change Lives · 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 ...
-
French Speaker Quality Systems Specialist
hace 3 semanas
Medtronic Bogotá, ColombiaCareers that Change Lives · 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 ...
-
Especialista de Aix
hace 3 semanas
SONDA IT Bogota, ColombiaSi estás buscando un nuevo desafío para innovar y transformar el futuro, entonces queremos que seas parte de nuestro equipo. Únete a la empresa latinoamericana líder en servicios de TI, un lugar dónde podrás impulsar tu carrera, adquirir conocimiento y desarrollarte profesionalme ...
-
Coordinador Bim
hace 3 semanas
Worley Bogota, Colombia**Coordinador BIM** **-** **BOG00RN** · **Company**: Worley · **Primary Location**: COL-CPD-Bogotá · **Job**: Engineering Design Systems (EDS) · **Schedule**: Full-time · **Employment Type**: Employee · **Job Level**: Experienced · **Job Posting**: Feb 16, 2024 · **Unposting Date ...
-
Gis Specialist
hace 3 semanas
Panagora Group Bogota, Colombia**Job Information**: · Project/Activity · - MELSAIndustry · - USAIDCity · - BogotaState/Province · - Bogota, D.C.Country · - ColombiaZip/Postal Code · HIghest Level of Education · - Master's DegreeWork Experience · - 5-7 years- Panagora Group is a woman-owned small business speci ...
-
Service Manager
hace 2 semanas
IBM Bogota, ColombiaIntroduction · As a Service Delivery Specialist, you are the face of IBM for our customers. Your clients' success depends on your ability to understand their needs and respond to requests for new services. This role is an integral part of both account planning and delivering supp ...
-
Senior Eds Specialist
hace 3 semanas
Worley Bogota, Colombia**Senior EDS Specialist (Administrador Aveva E3D)** · **-** · **BOG00L7** · **Company***: Worley · **Primary Location***: COL-CPD-Bogotá · **Job***: Engineering Design Systems (EDS) · **Schedule***: Full-time · **Employment Type***: Employee · **Job Level***: Experienced · **Job ...
Portuguese Speaker Quality Systems Specialist - Bogotá, Colombia - Medtronic
Descripción
Careers that Change Lives
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.
Come strengthen your specialized skills and enhance your expertise. We'll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that's best for you. Together, we can confront the challenges that will change the face of healthcare. Join us for a career that changes lives.
A Day in the Life
Must Haves
Nice to Haves
·1 year of experience working with quality systems or related areas
Our Commitment Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact. Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.