Quality Specialist I

Quality Specialist I

Englewood, CO
1 Year Contract with high possibilities of extension

Duties:

Client is a global medical technology leader dedicated to alleviating pain and improving quality of life.

Paragon 28, a Client 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.

The specialist will work closely with Quality, Engineering, Regulatory, and Operations teams to align legacy documentation with current standards and ensure readiness for controlled release within the new system environment.

Skills:

Essential Responsibilities and Duties

QMS Document Preparation & Windchill Integration

• 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.

Education:

Qualifications

• 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.