Quality Specialist II

TekWissen LLC

Job Location:

Englewood, CO - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Client is a publicly traded medical device company. Client designs develops manufactures and markets orthopedics products including knee hip shoulder elbow foot and ankle artificial joints and dental prostheses. client has operations in more than 40 countries around the world

Job Title: Quality Specialist II
Work Location: Englewood Colorado 80112
Duration: 11 Months
Job Type: Temporary Assignment
Work Type: Onsite

Job Overview

Client is seeking a Quality Specialist II (Temporary) to support Quality Management System integration activities.
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.

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.

Qualifications

Bachelors 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.

TekWissen Group is an equal opportunity employer supporting workforce diversity

Overview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Client is a publicly traded medical device company. Client designs develops manufactures and markets orthopedics products including knee hip shoulder elbow foot and ankle artificia...