Quality Systems Specialist/ Chile

Medtronic; Lo Barnechea; Presencial; CLP 12.000.000 - 18.000.000; Jornada completa

Descripción de la vacante

Medtronic Chile is seeking a Quality Auditor to oversee the development and maintenance of quality programs, ensuring compliance with regulatory standards and internal guidelines. The role involves coordinating audits, interpreting health regulations, and collaborating with operations to sustain high-quality processes.

The ideal candidate has a university degree in a health-related field, at least two years of audit experience, and advanced English for global collaboration.

Formación

• University degree in a health-related field (e.g., Pharmacist, Biomedical Engineer)
• At least two years of experience participating in internal audits, external audits, and regulatory inspections
• Knowledge of health sector regulatory requirements in Chile, particularly ISP
• Knowledge of quality standards and frameworks such as ISO 13485, GDP, or other applicable quality management systems
• Experience supporting quality processes in distribution, warehousing, logistics or supply chain environments is highly desirable
• Advanced English (ability to interact with global teams orally and in writing)

Responsabilidades

• Oversee the development and maintenance of quality programs, systems, processes and procedures to ensure policy compliance and service performance aligns with internal and external guidelines
• Provide expertise and guidance interpreting regulations and internal policies to guarantee compliance
• Collaborate with operational units to continuously monitor process analyses and ensure regulatory adherence

Conocimientos

Advanced English

Educación

University degree in health-related field (e.g., Pharmacist, Biomedical Engineer)

Herramientas

ISO 13485

GDP

Descripción del empleo

Onsite, Lo Barnechea, Santiago, Chile

Full time

R75862

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 Life

Somos líderes en tecnología y soluciones médicas impulsados por una misión, con un legado de integridad e innovación. Trabaja con nosotros para incentivar una mejor atención al paciente y colabora con toda la industria para que la asistencia sanitaria sea más asequible y accesible. Forma parte de una comunidad de expertos comprometidos con garantizar una asistencia sanitaria de calidad y asequible en todo el mundo. Venga a fortalecer sus habilidades especializadas y a mejorar su experiencia. Le apoyaremos con la formación, la tutoría, la orientación y las redes que necesita para avanzar, y le capacitaremos para que trabaje de la manera que más le convenga. Juntos, podemos afrontar los retos que cambiarán el panorama de la asistencia sanitaria. Únase a nosotros para desarrollar una carrera que cambia vidas. El puesto estará ubicado en Pudahuel, Santiago Metropolitana Region, Chile en un modelo Flexible.

Las responsabilidades pueden incluir las siguientes y se pueden asignar otras tareas:

• Supervisa el desarrollo y mantenimiento de programas, sistemas, procesos y procedimientos de calidad que garanticen el cumplimiento de las políticas y que el desempeño y la calidad de los servicios se ajusten a las normas y directrices internas y externas establecidas.
• Aporta su experiencia y orientación en la interpretación de polítesis, normativas regulatorias y/o gubernamentales, y reglamentos internos para garantizar el cumplimiento.
• Trabaja directamente con las entidades operativas para supervisar de manera continua los análisis de procesos, con el fin de hacer cumplir los requisitos y cumplir con las regulaciones.
• Lidera la preparación de auditorías e inspecciones, la resolución de los hallazgos de auditorías e inspecciones, y actúa como enlace con los grupos de auditoría y los inspectores durante todas las etapas de las auditorías.
• Elabora informes y/o la documentación necesaria (por ejemplo, acciones correctivas y preventivas) y los entrega a las partes interesadas pertinentes, tanto internas como externas.
• Coordina las solicitudes legales en apoyo de investigaciones gubernamentales o litigios.
• Garantiza que los programas y políticas de aseguramiento de la calidad se mantengan y modifiquen periódicamente.
• Facilita la aplicación de estándares uniformes en todo el mundo y permite el intercambio de mejores prácticas, fomentando así el cumplimiento de la misión de la empresa a nivel global.

Conocimientos y experiencia requeridos:

• Carrera universitaria en un área relacionada con salud, tales como Químico Farmacéutico, Bioingeniero, Ingeniero Biomédico u otras disciplinas afines.
• Al menos dos años de experiencia en participando en auditorías internas, externas e inspecciones regulatorias, incluyendo preparación, seguimiento y cierre de hallazgos
• Conocimiento de los requisitos regulatorios del sector salud en Chile, particularmente aquellos aplicables por el Instituto de Salud Pública (ISP).
• Conocimiento de estándares y marcos de calidad tales como ISO 13485, Good Distribution Practices (GDP) u otros sistemas de gestión de calidad aplicables
• Experiencia apoyando procesos de calidad dentro de entornos de distribución, almacén, logística o cadena e suministro es altamente deseable.
• Inglés Avanzado (capacidad para interactuar con equipos globales de forma oral y escrita)

Ubicación de la vacante

Pudahuel, Santiago Metropolitana Region, Chile

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).

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. For further information about the E-Verify program, please click here.

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