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
Medtronic is among the largest medical technology companies in the world. Through innovation and collaboration, Medtronic helps to alleviate pain, restore health, and extend life. Last year, our medical therapies for the treatment of over 40 major conditions, improved the lives of more than 75 million people around the world.The Quality Systems Specialist support Americas Customer Care and Order Operations Quality based on the Strategic Workforce Planning and Quality strategy for LATAM and Canada. This role is remote based in Colombia.
Responsibilities may include the following and other duties may be assigned:
- Provide 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
- Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
- Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
- Lead audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits
- Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external
- Co-ordinate legal requests in support of government investigations or litigations
- Ensure the quality assurance programs and policies are maintained and modified regularly
- Facilitate uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally
Required Knowledge and Experience:
- Bachelor’s degree
- Three years of work experience in quality role, regulatory affairs within pharma or medical devices industry
- Fluent in English
- Expertise in CAPA compliance & investigation techniques
- Knowledge with ISO 9001: 2015 and ISO 13485:2016
- Knowledge with Power BI and Auditing experience is advantageous.
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.
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