New · posted Oct 15
LivaNova · Medical Devices
Quality Engineer
- Arvada, CO
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
With a high degree of autonomy, person will perform quality work of a broad nature to achieve successful outcomes of departmental and company objectives.
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 position also analyzes product complaint returns and determines actions required to prevent recurrence or communicates the information to the manufacturer or creates process improvements.
This is an on-site position located at our office in Arvada, CO.
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. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. 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.
What you need
Education
Bachelor’s Degree in Technical and Scientific disciplines (Engineering, Physics, Chemistry, and Biology)
• 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, 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
• 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.
• 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.
• Must be willing to take on related duties as required in support of company and departmental objectives.
Travel Requirements
Occasional travel may be required.
What you'll do
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.
1. With respect to Nonconforming product handling, He/She will:
Collect and critically analyze data and take disposition decisions on nonconforming products identified in production.
Lead proper investigation to identify the causes of components / product failures (nonconforming products from production and complaints)
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.
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.
May notify suppliers of any non-conformance related to purchased material and evaluate corrective actions consistency versus internal controls.
With respect to the Design Control & Production and Process control, He/She will:
Establishes product quality control inspections/plans
Reviews process validation planning, protocols and reports
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
Identify opportunities for quality improvements in the production area and lead improvement plans
2. With respect to Analysis of Complaint data and Returned Products, He/She will:
Daily management of the assigned complaint handling activities.
Providing daily support, as needed for:
Customer-related processes involving use of the device.
Complaint evaluations and investigations.
Provides support for timely analysis to meet Customer Quality complaint and MDR reporting quality metrics.
Leads effective meetings, conducts presentations, establishes quality records.
Develops effective relationships with internal personnel and external stakeholders to assist customers and drive the resolution of customer complaints
He/She respects the Health and Safety Regulations in his/her field of competence. Performs other duties as may be required by their manager.
Pay and benefits
$75,000 a year
Employer providedPay 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
Health benefits – Medical, Dental, Vision
Personal and Vacation Time
Retirement & Savings Plan (401K)
Employee Stock Purchase Plan
Training & Education Assistance
Bonus Referral Program
Service Awards
Employee Recognition Program
Flexible Work Schedules
Where you'll work
Arvada, COOn-siteOpen in Maps (opens in a new tab)
More jobs in Arvada, COJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 4% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US157 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $75,000 | — | $75,000 |
| All US (middle half) | $59,000 | $78,500 | $94,000 |
This role: LivaNova's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not LivaNova's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 47 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Investigations and CAPA14
- Collaboration and leadership10
- Quality systems and risk7
- GMP and compliance4
- Documentation and SOPs2
- Validation and qualification1
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- FDA and partnersMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program
Company hiring pulse
LivaNova on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 2
- Locations
By discipline
- Quality2 67%
- Regulatory1 33%
By level
- Manager1 33%
- Senior & Principal1 33%
- Associate & Specialist1 33%
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Quality Engineer at LivaNova
Open until filled. $75K a year, employer provided.