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Quality Engineer Medical Device Jobs in Colorado

LivaNova PLC

Quality Engineer

Arvada, CO · On-site

$85 - $95/hr

... medical device manufacturing and distribution. The role evaluates non‑conforming products ... Support Quality Management for executing quality engineering activities related to design and ...

LivaNova

Quality Engineer

Arvada, CO · On-site

$85K - $95K/yr

The Quality Engineer will contribute to ensure that production and process control activities are ... Experience with MDSAP and Medical Device Requirements is a plus Must have proficiency with quality ...

Philips

Supplier Quality Engineer

Colorado Springs, CO · On-site

$63K - $100K/yr

Job TitleSupplier Quality Engineer The Supplier Quality Engineer supports supplier qualification ... You have knowledge of medical device regulations, QMS requirements, and standards, such as 21 CFR ...

LivaNova, PLC

Quality Engineer

Arvada, CO · On-site

$85K - $95K/yr

The Quality Engineer will contribute to ensure that production and process control activities are ... medical device manufacturing and distribution. Evaluates situations of non-conforming products ...

Philips

Supplier Quality Engineer

Colorado Springs, CO · On-site

$63K - $100K/yr

Job Title Supplier Quality Engineer The Supplier Quality Engineer supports supplier qualification ... You have knowledge of medical device regulations, QMS requirements, and standards, such as 21 CFR ...

LivaNova, PLC

Medical Device Assembler

Arvada, CO · On-site

$19.50 - $21/hr

Medical Device Production Assembler Build Products That Help Change Lives Arvada, CO | Full-Time ... Collaborate closely with engineering, quality, and operations teams. * Take ownership of your work ...

LivaNova

Medical Device Assembler

Arvada, CO · On-site

$19.50 - $21/hr

Medical Device Production Assembler Build Products That Help Change Lives Arvada, CO | Full-Time ... Collaborate closely with engineering, quality, and operations teams. * Take ownership of your work ...

LivaNova PLC

Quality Engineer (On-site)

Arvada, CO · On-site

$67.50 - $82.50/hr

... medical device manufacturing and distribution. He/she evaluates situations of non‑conforming products, collects and analyzes data to propose product disposition and CAPA's to address quality issues.

LivaNova

Quality Engineer (On-site)

Denver, CO · On-site

$74K - $95K/yr

The Quality Engineer will contribute to ensure that production and process control activities are ... medical device manufacturing and distribution. He/she evaluates situations of non-conforming ...

LivaNova, PLC

Quality Engineer (On-site)

Denver, CO · On-site

$74K - $95K/yr

The Quality Engineer will contribute to ensure that production and process control activities are ... medical device manufacturing and distribution. He/she evaluates situations of non-conforming ...

Highridge Medical

Sr Quality Design Engineer

Westminster, CO · On-site

$89K - $121K/yr

Sr Quality Design Engineer Principal Duties and Responsibilities: Serves as the design quality ... EU medical device regulations, design assurance, risk analysis techniques, and product testing ...

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All JobsQuality Engineer Medical Device JobsQuality Engineer Medical Device Jobs in Colorado

Quality Engineer Medical Device information

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$22

$38

$74

How much do quality engineer medical device jobs pay per hour?

As of Sep 7, 2026, the average hourly pay for quality engineer medical device in Colorado is $38.61, according to ZipRecruiter salary data. Most workers in this role earn between $26.06 and $48.27 per hour, depending on experience, location, and employer.

What does a quality engineer do in the medical device industry?

A Quality Engineer in the medical device industry is responsible for ensuring that medical devices meet all regulatory standards and quality requirements. They develop and implement quality assurance processes, perform risk assessments, and conduct inspections and audits to make sure products are safe and effective. Quality Engineers also collaborate with design, manufacturing, and regulatory teams to resolve quality issues and improve product reliability. Their work is crucial for maintaining compliance with standards such as ISO 13485 and FDA regulations.

What are the key skills and qualifications needed to thrive as a quality engineer in the medical device industry?

To thrive as a Quality Engineer in the medical device industry, you need a strong background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and engineering principles, often supported by a relevant engineering degree. Familiarity with quality management systems (QMS), risk analysis tools (like FMEA), and certifications such as CQE (Certified Quality Engineer) are typically required. Attention to detail, problem-solving, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills and qualifications are vital to maintain regulatory compliance, uphold product quality, and protect patient safety in a highly regulated environment.

How does a quality engineer in the medical device industry typically collaborate with cross-functional teams to ensure product compliance?

Quality Engineers in the medical device sector work closely with cross-functional teams such as design, manufacturing, regulatory affairs, and supply chain. They participate in design reviews, risk assessments, and process validations to ensure that products meet both internal quality standards and external regulatory requirements (such as FDA or ISO 13485). Regular collaboration involves reviewing documentation, addressing non-conformances, and implementing corrective actions. This teamwork is critical to proactively identify potential issues and maintain continuous product quality throughout the development and production lifecycle.

What is the difference between Quality Engineer Medical Device vs Quality Assurance Specialist Medical Device?

AspectQuality Engineer Medical DeviceQuality Assurance Specialist Medical Device
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, Six Sigma, ASQ certifications
Work EnvironmentDesign, development, manufacturing, and process improvementAuditing, compliance, documentation, and process verification
Employer & Industry UsageMedical device manufacturers, R&D labsMedical device companies, regulatory agencies, consulting firms

While both roles focus on quality in the medical device industry, a Quality Engineer Medical Device primarily works on product design, process development, and continuous improvement. In contrast, a Quality Assurance Specialist Medical Device emphasizes compliance, auditing, and ensuring adherence to regulatory standards. Both roles are essential for maintaining product safety and quality, but they differ in scope and daily responsibilities.

More about Quality Engineer Medical Device jobs

What are the most commonly searched types of Quality Engineer Medical Device jobs in Colorado?

The most popular types of Quality Engineer Medical Device jobs in Colorado are:

What are popular job titles related to Quality Engineer Medical Device jobs in Colorado?

For Quality Engineer Medical Device jobs in Colorado, the most frequently searched job titles are:

What job categories do people searching Quality Engineer Medical Device jobs in Colorado look for?

The top searched job categories for Quality Engineer Medical Device jobs in Colorado are:

What cities in Colorado are hiring for Quality Engineer Medical Device jobs?

Cities in Colorado with the most Quality Engineer Medical Device job openings:

Quality Engineer Medical Device jobs near you
Infographic showing various Quality Engineer Medical Device job openings in Colorado as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, 1% Temporary, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $80,319 per year, or $38.6 per hour.

Quality Engineer

LivaNova PLC

Arvada, CO • On-site

$85 - $95/hr

Other

Re-posted 5 days ago

Job description

Position Summary

With a high degree of autonomy, the Quality Engineer will contribute to ensuring 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, analyzes data, proposes product disposition, initiates CAPAs, and communicates findings to manufacturers or develops process improvements.

Responsibilities
  • Support Quality Management for executing quality engineering activities related to design and manufacture of products in compliance with the Quality Management System requirements and applicable regulations.
  • Collect and critically analyze data and take disposition decisions on non‑conforming products identified in production.
  • Lead proper investigations to identify causes of component/product failures (nonconforming products from production and complaints).
  • Generate risk evaluations for nonconforming products already distributed (Health Hazard Evaluation) to assist management in determining whether to stop shipment or initiate field action.
  • Lead CAPA projects and trend data to identify opportunities for future CAPAs.
  • Support external manufacturers of semi‑finished and finished products in managing any detected nonconformities, notifying suppliers of non‑conformance related to purchased material, and evaluating corrective action consistency versus internal controls.
  • Establish product quality control inspection plans, review process validation planning, protocols, and reports.
  • Preliminary review of change impact assessment to confirm quality requirements are met.
  • Maintain Risk Management files and collaborate in investigations into the causes of V&V failures.
  • Identify opportunities for quality improvements in the production area and lead improvement plans.
  • Daily management of assigned complaint handling activities related to customer use of the device, evaluating and investigating complaints, and providing timely analysis to meet Customer Quality complaint and MDR reporting quality metrics.
  • Lead effective meetings, conduct presentations, and establish quality records to support resolution of customer complaints.
  • Develop effective relationships with internal personnel and external stakeholders to assist customers.
Qualifications
  • 1‑3 years of related experience in Class II/III medical device manufacturing or related regulatory industry.
  • Knowledge of regulatory requirements (e.g., FDA, ISO13485).
  • Experience with MDSAP and Medical Device Requirements is a plus.
  • Proficiency with quality tools such as flowcharts, statistical data analysis, and mathematical reasoning.
  • Experience with CAPA and ability to analyze and problem‑solve.
  • Ability to work within a changing environment and engage a wide variety of personnel on all levels.
  • ASQ Certified Quality Engineer or other ASQ certifications are a plus.
  • Excellent written and verbal communication and presentation skills.
  • Ability to communicate across functional lines.
Physical Demands and Work Conditions
  • Sitting 60‑80%, standing & walking 20‑40%.
  • Repetitive work on computer 80%.
  • 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.
Education

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

Benefits and Compensation

Salary range: $85,000–$95,000 annually + annual bonus incentive.

Travel Requirements: Occasional travel may be required.

Equal Employment Opportunity

LivaNova values equality and diversity. The company is committed to ensuring that the recruitment process is fair, transparent, and free from unlawful discrimination. Selection is based on key demands/requirements for the role rather than bias or discrimination on the basis of legally protected classifications.

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