Quality Specialist I

LanceSoft Inc

Englewood, CO

JOB DETAILS
JOB TYPE
Full-time
SKILLS
Code of Federal Regulations, Documentation, Editing, Genetics, ISO (International Organization for Standardization), Quality System Requirements (QSR), Regulations, Technical Writing, Windchill PLM Software
LOCATION
Englewood, CO
POSTED
10 days ago
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. EEO Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.

About the Company

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LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/