Quality Engineer (On-site)

LivaNova

Denver (CO)

On-site

USD 67,500 - 82,500

Full time

14 days+

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Benefits offered by this job

Health benefits – Medical, Dental, Vision

Retirement & Savings Plan (401K)

Flexible Work Schedules

Training & Education Assistance

Job summary

A global medtech company is seeking a Quality Engineer to join their team in Denver, Colorado. In this role, you will ensure compliance with quality management systems and lead investigations of non-conforming products. The ideal candidate will have a Bachelor's Degree in a related field and 1-3 years of experience in medical device manufacturing. This position offers health benefits, retirement plans, and a base salary of $75,000 plus potential bonuses.

Qualifications

1-3 years of experience in Class II/III medical device manufacturing or related regulatory industry.
Experience with MDSAP and Medical Device Requirements is a plus.
ASQ Certified Quality Engineer or other ASQ Certifications is a plus.

Responsibilities

Ensure production activities comply with quality management systems.
Lead investigations of non-conforming products.
Establish product quality control inspections and plans.

Skills

Regulatory requirements knowledge (FDA, ISO 13485)

Quality tools proficiency (flowcharts, statistical analysis)

Problem-solving with CAPA experience

Communication skills (written and verbal)

Ability to analyze data

Education

Bachelor's Degree in Technical and Scientific disciplines

Job description

Overview

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. This role is part of LivaNova and contributes to quality engineering within a manufacturing environment.

This is an on-site position located at our office in Arvada, CO.

Position Summary

With a high degree of autonomy, the employee will perform quality work of a broad nature to achieve successful outcomes of departmental and company objectives. The Quality Engineer will 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. The role evaluates non-conforming products, collects and analyzes data to propose product disposition and CAPAs to address quality issues. The position also analyzes product complaint returns and determines actions required to prevent recurrence or communicates the information to the manufacturer or creates process improvements.

General Responsibilities

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.

Nonconforming product handling: collect and critically analyze data and take disposition decisions on nonconforming products identified in production.
Lead investigations to identify causes of component/product failures (nonconforming products from production and complaints).
Evaluate risk posed by observed NC on products already distributed (Health Hazard Evaluation) to help management determine if Stop Shipment and/or Field Action is initiated.
Lead CAPA projects and trend data to identify opportunities for future CAPA.
Where applicable, support external manufacturers of semi-finished and finished products in managing detected nonconformities.
Notify suppliers of non-conformance related to purchased material and evaluate corrective actions consistency versus internal controls.
Design Control & Production and Process Control: establish product quality control inspections/plans; review process validation planning, protocols and reports; perform preliminary review of the change impact assessment to confirm quality requirements are met; establish and maintain Risk Management files; collaborate in investigations into the cause of V&V failures; identify opportunities for quality improvements in the production area and lead improvement plans.
Analysis of Complaint data and Returned Products: daily management of the assigned complaint handling activities; provide daily support as needed for customer-related processes involving use of the device; conduct complaint evaluations and investigations; support timely analysis to meet Customer Quality complaint and MDR reporting quality metrics; lead effective meetings, conduct presentations, and establish quality records; develop effective relationships with internal personnel and external stakeholders to assist customers and drive resolution of customer complaints.

Employee respects Health and Safety Regulations in their field of competence. Performs other duties as may be required by their manager.

Skills And Experience

Minimum related work experience of 1-3 years in Class II/III medical device manufacturing or related regulatory industry.
Knowledge of regulatory requirements (e.g., FDA, ISO 13485) as required for the position.
Experience with MDSAP and Medical Device Requirements is a plus.
Must have proficiency with quality tools such as flowcharts, statistical data analysis, and mathematical reasoning.
Ability to analyze and problem-solve with CAPA experience.
Ability to work within a changing environment and with a wide variety of personnel at all levels.
ASQ Certified Quality Engineer or other ASQ Certifications is a plus.
Excellent communication (written and verbal) and presentation skills; able to communicate across functional lines.
Physical requirements: Sitting 60-80%, standing/walking 20-40%, repetitive computer work 80%.
Oral and written comprehension; must be able to work in a clean room environment and tolerate chemical odors; able to work in a lab environment and tolerate the smell and sight of blood.
Willingness to take on related duties as required to support company and departmental objectives.

Education

Bachelor’s Degree in Technical and Scientific disciplines (Engineering, Physics, Chemistry, and Biology).

Travel Requirements

Occasional travel may be required.

Pay Transparency

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

Employee Benefits Include