LivaNova

Quality Engineer (On-site)

Denver, Colorado, United States · Mid

Sponsorship not specified$60k-$80kDetected 31 days ago

Data AnalysisFDA RegulatoryMedical 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 proper investigation to identify the causes of components / product failures (nonconforming products from production and complaints)
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.
With respect to the Design Control & Production and Process control, He/She will:
Perform preliminary review of the change impact assessment to confirm that quality requirements are met
Establish and maintain Risk Management files
Collaborates in the investigations into the cause of V&V failures

Occasional travel may be required.
Bachelor's Degree in Technical and Scientific disciplines (Engineering, Physics, Chemistry, and Biology)
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.

Minimum related work experience of 1-3 years in Class II/III medical device manufacturing or related regulatory industry.
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.

A reasonable estimate of the annual base salary for this position is $75,000 + discretionary annual bonus.
Pay ranges may vary by location.

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.
Generate the evaluation of the risk posed by the observed NC on products already distributed (Health Hazard Evaluation) to help management determine if Stop Shipment and/or Field Action is initiated.

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.