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Quality Specialist

ICONMA, LLC

Englewood, CO

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JOB DETAILS
SALARY
$24.41–$26 Per Hour
SKILLS
Auditing, Business Administration, Collocation, Communication Skills, Detail Oriented, Documentation, Editing, Health Plan, Healthcare, Medical Equipment, Metadata, Presentation/Verbal Skills, Quality Assurance, Quality Control, Quality Engineering, Quality Management, Technical Writing, Windchill PLM Software, Writing Skills
LOCATION
Englewood, CO
POSTED
30+ days ago
Our Client, a Medical Devices / Healthcare company, is looking for a Quality Specialist for their Englewood, CO location.
 
Responsibilities:
  • Perform technical writing and editing of quality system documents, including procedures, work instructions, forms and templates to enhance clarity, consistency, and readiness for migration into Windchill.
  • Perform document integration activities, including formatting updates, metadata alignment, revision verification, and reference accuracy.
  • Assist with mapping document attributes, lifecycle states, and approval workflows into Windchill.
  • Support training and onboarding activities related to updated document workflows where needed.
  • Contribute to continuous improvement of documentation practices during system integration.
  • Documentation Quality & Compliance
  • Ensure documents meet applicable regulatory and quality system requirements (21 CFR 820, ISO 13485, MDR as applicable).
  • Maintain accurate tracking of document status and deliverables tied to project timelines.
  • Support audit readiness activities, including the implementation of an employee audit awareness program designed to strengthen auditor interactions and enhance overall inspection readiness.
 
Requirements:
  • Bachelor’s degree in a related field, such as quality management, engineering, or business administration or another quality field.
  • Minimum of 3-5 years of experience in documentation control or quality assurance.
  • Strong knowledge of regulatory requirements and industry standards related to documentation control.
  • Experience with electronic document management systems, Windchill experience preferred.
  • Excellent written and verbal communication skills.
  • Strong attention to detail and ability to work independently or part of a team.
 
Why Should You Apply?  
ICONMA is an Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to any status protected by applicable law.
 

About the Company

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ICONMA, LLC