Costa Rica Job Openings
Medtronic
Assoc Quality Syst Spec (Temporary position)
Alajuela
FULL TIME
September 12, 2024
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
Assoc Quality Systems Spec (Hybrid) | Temporary 6 months | CAPA and e-Doc Control
CRITICAL REQUIRIMENTS
General
- Fluent in English: written and spoken (supports USA Customer from Costa Rica).
- US Visa: business (B1) or tourist (B2), probability to travel.
- Knowledge about FDA Title 21 CFR Part 820 and ISO13485:2016
- Requires University Bachelor degree (engineering or equivalent).
Soft Skills:
- Great customer service.
- Emotional intelligence.
- Initiative and positive approach for collaborating with team and internal customers.
- Continuous improvement thinking.
CAPA knowledge:
- Knowledge about CAPA and problem solving (DMAIC, root cause analysis, effectiveness)
- Proficient in Microsoft Excel: data analysis, trending, pivot tables for CAPA metrics.
- Familiar with Section 820.100 and "Continuous improvement (ISO13485:2016)"
- This position will maintain the CAPA process for Internal Customer located at USA
Change Management knowledge: FDA 21CFR Part 820 and ISO 13485:2016
- Familiar with the Section: "Documentation requirements" & "Documentation Control (820.40)"
- Attention to detail and strict follow of procedures.
- This position will process change orders related to electronic control of documents as Change Analyst Role.
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.
- Leads audit and inspection preparation, resolution of audit and inspection findings.
- Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
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 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.
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 90,000+ 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.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ 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.
Learn more about our business, mission, and our commitment to diversity
here
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