- 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 Italian
- 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.
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Italian 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.
Usuarios de profesión Italian Speaker Quality Systems Specialist en Bogotá
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Melisa Melisa Posso Chaves
Especialista de producto-Ventas