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Quality Engineer Medical Device Jobs in Colorado

Medtronic

Design Quality Engineer II

Lafayette, CO · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Design Quality Engineer II applies Design Controls, Risk Management, and Change Control ... Experience in the medical device industry or another regulated industry with similar quality and ...

LivaNova

Quality Engineer

Arvada, CO

$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 ...

Medtronic

Design Quality Engineer II

Lafayette, CO · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Design Quality Engineer II applies Design Controls, Risk Management, and Change Control ... Experience in the medical device industry or another regulated industry with similar quality and ...

Philips

Supplier Quality Engineer

Colorado Springs, CO

$63K - $100K/yr

  • Retirement

  • PTO

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 ...

Medtronic

Design Quality Engineer II

Lafayette, CO · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Design Quality Engineer II applies Design Controls, Risk Management, and Change Control ... Experience in the medical device industry or another regulated industry with similar quality and ...

Philips

Supplier Quality Engineer

Colorado Springs, CO · On-site

$63K - $100K/yr

  • Retirement

  • PTO

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 ...

Actalent

Lead Senior Quality Engineer

Longmont, CO · On-site

$53 - $72/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Lead Senior Quality Engineer We are seeking an experienced Lead Design Assurance Quality Engineer ... Class II / Class III medical device experience. * Exposure to implantable devices. * Statistical ...

LivaNova

Quality Engineer (On-site)

Denver, CO

$74K - $95K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

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

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

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 ...

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

Quality Engineer Medical Device information

See Colorado salary details

$22

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$74

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

As of Aug 13, 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 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.

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.
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, 79% Full Time, 15% Part Time, and 5% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $80,319 per year, or $38.6 per hour.

Quality Assurance Engineer I

CoorsTek, Inc.

Grand Junction, CO • On-site

Full-time

Re-posted 3 days ago

CoorsTek rating

8.2

Company rating: 8.2 out of 10

Based on 28 frontline employees who took The Breakroom Quiz

Job description

It's exciting to work for a company that makes the world measurably better.
We're committed to bringing safety, quality, and customer focus to the business of advanced ceramics manufacturing.
Job Title
Quality Assurance Engineer I
CoorsTek is seeking a Quality Assurance Engineer I to join the Bioceramics Quality team in Grand Junction, CO. This is a key growth-enabling role responsible for partnering with medical device customers on regulatory and product qualification submissions, supporting expansion into new geographies and customer programs. The ideal candidate brings a background in medical device quality or regulatory affairs and is passionate about solving complex technical challenges at the intersection of advanced materials and patient care.
Key Responsibilities
  • Serve as the primary quality engineering liaison for internal and external medical device customer programs, supporting regulatory and product technical submissions (FDA 21 CFR 820, ISO 13485).

  • Partner with customers to complete qualification activities for CoorsTek Bioceramics as a supplier, including process flow documentation, risk documentation, measurement system comparisons, and material property testing.

  • Design, install, and continually evaluate quality assurance and control methods and systems.

  • Develop standards, procedures, and work instructions to provide quality guidance and facilitate training.

  • Act as subject matter expert in internal auditing, CAPA, and change management activities; conduct and support internal and external audits.

  • Develop sampling plans and statistical methods for manufacturing and inspection; determine control points and charting methods.

  • Coordinate and participate in material review activities to determine nonconforming product dispositions and corrective actions.

  • Develop, generate, and analyze reports and returned products to identify trends and facilitate corrective action and quality improvements.

  • Interface with engineering and production teams to design fixtures and processes that ensure measurement system effectiveness.

What Makes This Role Exciting
  • Key growth enabler for the Bioceramics business - you'll partner directly with new customers to expand geographic footprint and support increasing production demand.

  • Forefront of new product and material development - solving novel technical challenges in advanced materials used in medical applications.

  • High visibility role with direct impact on CoorsTek's ability to serve medical device OEMs and grow its position as a critical supplier.

Requirements
Education
  • Bachelor's degree in a related technical field; Professional Engineer (PE) and/or ASQ Certified Quality Engineer (CQE) a plus.

Experience
  • Minimum 3 years' relevant experience within the medical device industry with a focus on quality or regulatory product submissions; manufacturing experience preferred.

  • Background in medical device design, regulatory affairs, or quality management strongly preferred; ceramics or advanced materials experience a plus but not required.

  • Demonstrated experience managing the technical aspects of qualifying medical devices for patient use, including recommending ISO standards, testing processes, and design controls.

Technical Skills & Competencies
  • Working knowledge of medical device regulated quality or regulatory standards (FDA 21 CFR 820, ISO 13485).

  • Ability to recommend and implement ISO standards, testing processes, design controls, and regulatory affairs requirements.

  • In-depth knowledge of statistical techniques (SPC, DOE, capability studies); ability to identify, analyze, and define solutions for continuous improvement.

  • Advanced math skills; ability to interpret and communicate technical data in mathematical or diagram form.

  • Excellent communication skills; ability to read, analyze, and present complex technical information to diverse audiences.

  • Effective collaborator across engineering, production, and customer-facing teams.

  • CMM/fixture interface experience a plus, but not required.

Target Hiring Range
: USD 75,000.00 - USD 91,000.00
Actual compensation is commensurate with experience, skills and education. CoorsTek strives to give all qualified applicants equal opportunity and to make selection decisions on job related factors. Do not provide any information on the application which will indicate your race, color, religion, national origin, sex, age, disability, sexual orientation, gender identity, pregnancy, genetic information, veteran status, or any other status protected by law or regulation.
If you like working for a company that makes a real difference in the world, you'll enjoy your career with us!

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