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Quality Systems Spec

hace 1 mes

Bogota, Colombia Medtronic A tiempo completo

**Careers that Change Lives**

**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
- Provides 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.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
- 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.

**Must Have: Minimum Requirements**
- Bachelor’s degree in life science, engineering or related degree. (eg Pharmacy, Biomedical Engineering).
- Advance English level skills.
- 2 or 3 years of experience in quality role or related.
- Communication skills.
- Resolution of conflicts and critical thinking.
- Previous experience supporting quality system audits.
- Experience writing and reviewing of technical documentation.
- Strong technical writing and documentation review skills with high detail attention.
- Teamplayer.
- Great communication skills.
- Strong critical thinking and analytical skills.

**Nice to Have**
- Project management Skills.
- 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.
- Influence management skills: ability to work constructively across all functions of the organization and build relationships

**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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)