Quality Systems Analyst

Beschreibung:

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 are leaders in medical technology and solutions, driven by a mission and built on a legacy of integrity and innovation. We are searching for a Quality Systems Analyst to help improve patient care and collaborate across the industry to make healthcare more affordable and accessible. Be part of a community of experts committed to advancing high-quality, cost-effective healthcare worldwide.

The Quality Systems Analyst will support Brazil Post Market Vigilance activities related to Product Complaint Handling. The successful candidate will be focusing on Reportability Decisions and MDR processes in Regions Quality Post Market Vigilance for the country. We are offering a flexible working arrangement with presence in our office in São Paulo, Brazil.

Responsibilities may include the following and other duties may be assigned.
* Ensure Medical Device Reports are submitted timely with high-quality of information to ANVISA.
* Maintain stability and efficiency of Regions Quality PMV processes with an intention to improve and refine the process.
* Improve Vigilance timeliness performance.
* Ensure PMV activities are executed as defined in applicable quality documents.
* Responsible for the execution, monitoring, and closure of Vigilance activities throughout LATAM.
* Responsible for the implementation and maintenance of quality metric and monthly reports on PMV activities.
* Ensure that the Company's agreed quality standards (including ISO13485) are maintained with regards to products, procedures, policies, operations, and customer contact.
* Provide support and services to the Brazil local QARA based on defined Service Level Agreement.

Required Knowledge and Experience:
* Bachelor's Degree required in Medical, Biological Science, Pharmaceutical Science, Engineering, or any related discipline
* With minimum of 2 to 3 years of experience in Post Market Surveillance, Vigilance or QA/RA role.
* Advanced English language, good speaking, reading and writing
* Computer literacy including sound knowledge of the MS Office Suite or software
* Good understanding of GDP and its implementation is required.
* Sound awareness and knowledge of ISO 13485 and its implementation.
* Strong experience and knowledge in regulatory requirements for adverse event reporting for approved devices is a great advantage.

Experience in writing comprehensive regulatory reports is an advantage.

We Offer
Medtronic is recognized by the Great Place to Work (GPTW) and, in 2022, reached tenth place in the ranking of best companies to work for in the industry and services category. This recognition reinforces our ongoing commitment to the well-being of our employees. Our benefits are carefully designed to promote quality of life, and this is why we work with the best suppliers on the market. Find out more about what we offer in our benefits package:
Private Pension Plan, Transport voucher, reimbursement for charter or parking, Flexible meal voucher, medical assistance and Dental assistance (for you and your legal dependents (spouses, children and stepchildren), Life insurance, Gympass, childcare assistance, pharmacy discount, ESPP (discounted share purchase program), educational subsidy + idiom program.

Wellness programs:
- Birthday Day Off
- Maternity leave 6 months + Paternity leave 20 days
- Paid Family Leave Program of up to 6 weeks.

NOTE: OPTION of transportation + hybrid work will not be available for positions in the clinical and sales areas, as well as for positions that do not have working time control.

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.

About Medtronic
Bold thinking. Bolder actions. We are 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 90,000+ passionate people. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world.
In everything we do, we are engineering the extraordinary.

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