LivaNova

Quality Engineer (On-site)

Remote, Colorado, United States of America · Mid

Sponsorship not specified$60k-$80kDetected 103 days ago

Data AnalysisMedical DevicesCommunicationPublic Speaking

About the role

The Quality Engineer will contribute to ensure that production and process control activities are conducted in compliance with the company quality management system and the international regulations governing medical device manufacturing and distribution.
He/she evaluates situations of non-conforming products, collects and analyses data to propose product disposition and CAPA's to address quality issues.
This is an on-site position located at our office in Arvada, CO.

He/she supports Quality Management for executing the quality engineering activities related to the design and manufacture of the products in compliance with the Quality Management System requirements and the regulations of the countries where the franchise distributes and sells products.
Lead CAPA projects and trend data to identify opportunities for future CAPA.
Whenever applicable support external manufacturers of semi-finished and finished products in the management of any detected nonconformities.
Providing daily support, as needed for: Customer-related processes involving use of the device.
Provides support for timely analysis to meet Customer Quality complaint and MDR reporting quality metrics.
Leads effective meetings, conducts presentations, establishes quality records.

Occasional travel may be required.
Bachelor's Degree in Technical and Scientific disciplines (Engineering,
With a high degree of autonomy, person will perform quality work of a broad nature to achieve successful outcomes of departmental and company objectives.
This position also analyzes product complaint returns and determines actions required to prevent recurrence or communicates the information to the manufacturer or creates process improvements.
Performs other duties as may be required by their manager.
Bachelor's Degree in Technical and Scientific disciplines (Engineering, Physics, Chemistry, and Biology) Travel Requirements: Occasional travel may be required.

Experience with MDSAP and Medical Device Requirements is a plus
Must have proficiency with quality tools such as flowcharts, statistical data analysis, mathematical reasoning
Ability to analyze and problem-solve with CAPA experience
Ability to work within a changing environment.
Ability to work with a wide variety of personnel on all levels and utilize constructive confrontation
Excellent communication (written and verbal) and presentation skills.
Able to communicate across functional lines.
Sitting 60-80%, standing & walking 20-40%
Repetitive work on computer 80%
Oral and written comprehension
Must be able to work in a clean room environment and tolerate chemical odors.
Must be able to work in a lab environment and tolerate the smell and sight of blood.

A reasonable estimate of the annual base salary for this position is $75,000 + discretionary annual bonus.
Pay ranges may vary by location.
Welcome to innovation.
Welcome to your new life.
We treat our work as if lives depend on it - because they do.
As a people-oriented company, our employees around the world are fully committed to making the world a better place.

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds.
Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future.

As a people-oriented company, our employees around the world are fully committed to making the world a better place.
Join our talented team members worldwide to become a pioneer of tomorrow-because at LivaNova, we don't just treat conditions - we aspire to alter the course of lives.

This listing is sourced directly from LivaNova's careers page and normalized into a canonical job model.