Quality Specialist I

Position Title: Quality Specialist I
Work Location: Englewood CO
Assignment Duration: 12 Months
Work Schedule: Full Time (40 hours/week)

Position Summary:
The Client is a global medical technology leader dedicated to alleviating pain and improving quality of life.
The company focused on orthopedic medical devices for the foot and ankle, is seeking a Quality Specialist II (Temporary) to support Quality Management System integration activities.

Job Overview
The Quality Specialist II will support a cross-functional initiative to prepare and migrate Quality Management System documentation into Windchill. This role focuses on reviewing, remediating, standardizing, and organizing quality and engineering documents to ensure accuracy, completeness, and compliance prior to system integration.

Key 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.
· 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.

Qualification & Experience:
· 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.

Working Conditions & Physical Demands:
Travel None

 

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $23.00/hr.