Quality Systems Spec

**Careers that Change Lives**

**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
- Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.
- Lead/Participate in meetings to support the correct selection and qualification of supplier that may affect product reliability and may affect Medtronic service.
- Provide guidance and support to countries for the correct segmentation of new suppliers and Quality impact definition for new distributors.
- Lead Supplier and Distributor board where different process matters are discussed.
- Process owner of supplier or distributor Management processes in the region.
- Ensuring alignment with countries about regulations to speed up qualification process.
- Resolution of issues as required to complete daily work
- Provide analytical support for key metrics and operational reports.
- Provide constantly update to the leaders stakeholders or partners responsibles for the supplier/distributor approval.
- Train and mentor any supplier and distributor if need it.
- Prepare update and monitor audit, performance evaluation schedules for supplier and distributor process.
- Be a change agent for the organization. Identify, facilitate, and implement changes to improve efficiency, compliance and reduce complexity of processes as required.
- Participate and support Quality System Audits in in the regions supported.
- Operate within compliant quality system environments.
- Foster cross-functional partnerships and mutual understanding of recalls and field corrective actions.

**Must Have: Minimum Requirements**
- Bachelors degree required
- Requires a bachelor’s degree in life science or related degree
- Fluent in English.
- Ability to travel and work virtually with all parts of the region.
- 3 or more years’ experience in quality role.
- Previous experience supporting quality system audits.
- Strong technical writing and documentation review skills.
- Strong critical thinking and analytical skills.

**Nice to Have**
- 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.
- Good understanding of Latam regulations for Medical Devices and Drugs regarding Complaint Handling/Mandatory Medical Devices Problem Reporting, Adverse Events reporting and Recalls (basic understanding of International regulations).
- Influence management skills; ability to work constructively across all functions of the organization and build relationships
- Experience writing and reviewing of technical documentation.

**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 physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)