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Quality
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18000J4R Requisition #
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Careers that Change Lives 

Ensures that the Facilities under responsibility have an established Quality System is compliant with all applicable regulations for each facility as required, including the Food and Drugs Administration Quality System Regulations 21 CFR 820, EN ISO 13485:2012 / EC: 2012, Medical Device Directive (93/42/EEC), Canadian Medical Device Regulation (CMDR), Japanese Good Manufacturing Practices (J-GMP), ANVISA Resolution RDC No. 16 (Brazilian Medical Device Regulation).


A Day in the Life

Responsibilities may include the following and other duties may be assigned.

 
  • Quality Management System Representative for the San Isidro Facility.
  • Manage the Sao Sebastiao Brazil and Grenoble France quality department to ensure alignment with applicable regulations and defined divisional strategy.
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
  • 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.
 
 
Organizational Relationship

Supervises: France Quality Manager, San Isidro Quality Systems Manager, Sao Sebastiao Quality Manager, San Isidro Quality Operations Manager-Sutures, San Isidro Quality Operations Manager- Devises, San Isidro Quality Planning/Suppliers Manager.

 


Must Have

Minimum of 10 years of relevant experience with 7+ years of managerial experience in medical devices industry.

Competencies: Champions Integrity and Trust, Managerial Courage, Costumer Focus, Learning Change Agility, Builds Effective Teams, Manages Vision and Purpose, Manages Diversity, Drive for Results, Business Acumen.

 
Nice to Have 
Master Degree
15 years in Medical Devices Industry, 10 years in Quality
 
 
 

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. 

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. 

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. 

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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