Quality Systems Spec

hace 1 semana

Alajuela, Costa Rica Medtronic A tiempo completo

**Careers that Change Lives**

Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.

Experience what it’s like to work at a company with an exciting product pipeline full of patented inventions driving innovation in the healthcare space.

**A Day in the Life**

As an Quality Systems Specialist you will be a focal point for the processing and initiation of changes to documentation that is directly related to our products and to the Quality Management System vital to our medical devices.

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
- Bachelors degree required
- Quality management or document control experience
- Working knowledge of Microsoft Office tools, desktop publishing software experience (Microsoft Office Suite, Adobe Acrobat)
- Familiar with modern ERP systems, PLM systems and manufacturing documentation (i.e. BOMs, item masters, DHF, DMR, etc.)
- Bilingual English - Spanish Communication and excellent written and verbal communication. (C1 or B2+).
- Sound CAPA / Root Cause Analysis skills.

**Nice to Have**
- Project Management experience.
- Sound working knowledge of Risk Management Principles.
- Analytical skills and decision-making.
- Strong analytical, planning, Quality, regulation, and organizational skills.
- Knowledge of Six Sigma Methodology and Lean Manufacturing.
- Proficiency in Project Management.
- Able to work independently and within a team.
- Must be amenable to work on a night shift schedule.

**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)

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