Quality Specialist I

Quality System Management Specialist

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.