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Biomedical Quality Engineer Jobs in Colorado (NOW HIRING)

... biomedical, semiconductor, industrial, consumer products, scientific, security, defense and ... We are presently seeking a Quality Engineer that be responsible for ensuring product and process ...

... biomedical, semiconductor, industrial, consumer products, scientific, security, defense and ... We are presently seeking a Quality Engineer that be responsible for ensuring product and process ...

Senior Quality Engineer

Englewood, CO · On-site

$97K - $140K/yr

Bachelor's degree in Biomedical Engineering, Quality Management, or a related technical field. * 5+ years of experience in quality engineering or quality assurance roles within a manufacturing or ...

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Biomedical Quality Engineer information

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

AspectBiomedical Quality EngineerMedical Device Quality Specialist
CredentialsBachelor's in Biomedical Engineering, Quality Certifications (e.g., CQE)Bachelor's in Life Sciences or Biomedical, Quality Certifications (e.g., CQE)
Work EnvironmentManufacturing, R&D labs, regulatory complianceRegulatory agencies, manufacturing, quality assurance
Industry UsageMedical device manufacturing, biotech firmsMedical device companies, healthcare institutions
Job FocusDesign validation, process improvement, complianceAudits, documentation, regulatory submissions

The Biomedical Quality Engineer and Medical Device Quality Specialist roles both focus on ensuring medical device quality and compliance. The engineer typically works on product development and process improvements, while the specialist handles audits and regulatory documentation. Both roles require similar certifications and are vital in the medical device industry.

Infographic showing various Biomedical Quality Engineer job openings in Colorado as of September 2026, with employment types broken down into 94% Full Time, 3% Part Time, and 3% Contract. Highlights an 88% In-person, 6% Hybrid, and 6% Remote job distribution.
Excelitas Technologies
Electrical Equipment, Appliance, and Component Manufacturing • 5 - 10K employees

$100K - $130K/yr

Full-time

Medical, Dental, Vision, Retirement

Re-posted 16 days ago


Key responsibilities

  • Review, investigate, and disposition nonconforming product, ensuring appropriate containment, risk assessment, corrective actions, and timely closure of quality issues.

  • Support day-to-day production quality activities, providing guidance on product acceptance, quality requirements, deviations, and disposition decisions.

  • Lead investigations into product, process, and customer quality issues using structured problem-solving and root cause analysis methodologies.


Excelitas Technologies rating

8.0

Company rating: 8.0 out of 10

Based on 10 frontline employees who took The Breakroom Quiz


Job description

ENABLE your future through light.

Excelitas is a global technology leader with more than 7,500 employees, focused on delivering market-driven solutions to fulfill the illumination, optical, detection and imaging needs of OEMs and end-users across the biomedical, semiconductor, industrial, consumer products, scientific, security, defense and aerospace sectors.

ENGAGE with us today and make your contribution to the future! Join the team that leading technology companies turn to for cutting-edge photonic innovation. At Excelitas Technologies you are how we EXCEL.

We are presently seeking a Quality Engineer that be responsible for ensuring product and process quality through risk-based decision making, data analysis, investigation of quality issues, and implementation of effective corrective actions.

Main responsibilities:

  • Review, investigate, and disposition nonconforming product, ensuring appropriate containment, risk assessment, corrective actions, and timely closure of quality issues.
  • Support day-to-day production quality activities, providing guidance on product acceptance, quality requirements, deviations, and disposition decisions.
  • Lead investigations into product, process, and customer quality issues using structured problem-solving and root cause analysis methodologies.
  • Develop, implement, and verify the effectiveness of corrective actions to prevent recurrence and improve product and process performance.
  • Monitor and analyze quality metrics, process performance data, SPC, and MSA results to identify trends, risks, and opportunities for improvement.
  • Support development and maintenance of risk management activities, including pFMEAs and associated risk reduction actions.
  • Assess the quality impact of manufacturing, process, equipment, material, and design changes and support implementation of approved changes.
  • Serve as the primary quality contact for assigned products, manufacturing processes, and/or customers, facilitating effective communication and resolution of quality-related issues.
  • Partner with Manufacturing, Engineering, Supply Chain, and other functions to drive quality improvements and resolve complex quality challenges.
  • Support internal, customer, supplier, and certification audits by providing objective evidence, investigation records, corrective action documentation, and quality performance data.
  • Participate in continuous improvement initiatives that improve product quality, process capability, operational efficiency, and customer satisfaction.
  • Other duties as assigned

Requirements:

  • Bachelor's degree in Engineering, Manufacturing, Quality, Physical Sciences, or a related technical discipline, or equivalent combination of education and experience.
  • 3+ years of Quality Engineering experience in a manufacturing environment.
  • Experience investigating quality issues, performing root cause analysis, and implementing corrective actions.
  • Experience supporting manufacturing processes and product quality activities.
  • Strong analytical and problem-solving skills with the ability to interpret data and make sound quality decisions.
  • Working knowledge of quality tools and methodologies such as SPC, MSA, FMEA, CAPA, 5 Why, and Root Cause Analysis.
  • Ability to independently identify problems, assess risk, determine appropriate actions, and drive issues to closure with minimal supervision.
  • Strong written and verbal communication skills, including technical writing and customer communications.

Preferred 

  • Experience supporting customer-facing quality activities.
  • Experience managing customer complaints and/or RMAs.
  • ISO 9001 internal auditor or lead auditor training.
  • Strong background in statistics, SPC, and process capability analysis.
  • Experience with Power BI, SQL, Minitab, or similar analytical tools.
  • Experience with ERP systems such as SAP.
  • Experience in precision manufacturing, regulated industries, or other technical manufacturing environments.

Benefits start day 1: Medical, Dental, Vision, 401K, Holiday Pay, PAID Maternity/Paternity leave, Tuition Reimbursement, Long-term and Short-term disability.

Pay Range:  $100,000 - $130,000 per year, depending on experience.

Excelitas is a global technology leader with more than 7,500 employees, focused on delivering market-driven solutions to fulfill the illumination, optical, detection and imaging needs of OEMs and end-users across the biomedical, semiconductor, industrial, consumer products, scientific, security, defense and aerospace sectors.

ENGAGE with us today and make your contribution to the future! Join the team that leading technology companies turn to for cutting-edge photonic innovation. At Excelitas Technologies you are how we EXCEL.

Our facility in Boulder, Colorado has key functions in Research and Development, Operations, Production, and other disciplines. This facility specializes in the manufacturing of ultra-precision optical components, optical thin film coatings and optical sub-assemblies for demanding applications in lasers, materials processing, instrumentation, life sciences, avionics, and defense.

This site offers capabilities that include substantial design and engineering resources, comprehensive optical fabrication and coating capabilities, advanced assembly technology and an extensive in-house metrology lab.

#LI-FM1 #LI-Onsite

This position requires the use of information which is subject to the International Traffic in Arms Regulations (ITAR) 

Visa sponsorship is not available for any position at Excelitas 

Equal Opportunity/Affirmative Action Employer

Minorities/Females/Disability/Veteran/Gender Identity/Sexual Orientation

Excelitas is seeking leaders and innovators to join our global team!

Visit: https://jobs.excelitas.com/


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