Sr Quality Systems Specialist

hace 1 semana

Bogotá, Colombia Medtronic A tiempo completo

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**:We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.
The Senior Quality Systems Specialist develops and maintains quality assurance programs to ensure that the performance and quality of Medtronic products conform to established standards and agency guidelines. Primary job responsibilities include CAPA management, audit program management and Quality Management System Improvements. This position will be a remote position in Bogotá.

**Responsibilities may include the following and other duties may be assigned**:

- Quality Assurance Leadership - Oversee quality programs, systems, and compliance with internal/external regulations, driving CAPA management, audits, inspections, and continuous improvement initiatives
- Regulatory & Compliance Expertise - Provide guidance on domestic and international medical device regulations, risk management, and ensures adherence to ISO 13485 and FDA QSR (21 CFR Part 820)
- Audit & Inspection Management - Lead preparation, resolution of findings, and coordination with auditors/inspectors throughout all audit stages, including external/internal inspections
- Collaboration & Coaching - Support process improvement projects, coaches CAPA owners, partners with cross-functional teams, and coordinates legal requests tied to investigations or litigation

**Required Knowledge and Experience**:

- Bachelor’s degree
- Fluent in English
- Five years of relevant experience in quality (or master’s with 3+ years), CAPA compliance expertise, strong auditing background
- Knowledge in ISO 13485:2016 is advantageous
- Master’s degree in engineering, Program Management, or Compliance 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.

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