Quality Specialist I

Job Title: Quality Specialist I (Temporary)

Job Overview:

• Support Quality Management System (QMS) integration activities.
• Prepare and migrate QMS documentation into Windchill.
• Review, remediate, standardize, and organize quality and engineering documents.
• Ensure document accuracy, completeness, and compliance before system integration.
• Work with Quality, Engineering, Regulatory, and Operations teams.
• Align legacy documentation with current standards.
• Ensure readiness for controlled release in Windchill.

Essential Responsibilities and Duties

QMS Document Preparation & Windchill Integration

• Perform technical writing and editing of quality system documents.
• Work on procedures, work instructions, forms, and templates.
• Enhance document clarity, consistency, and migration readiness for Windchill.
• Perform document integration activities.
• Update document formatting.
• Align metadata.
• Verify document revisions.
• Ensure reference accuracy.
• Assist with mapping document attributes into Windchill.
• Assist with lifecycle states mapping.
• Assist with approval workflow mapping.
• Support training activities related to updated document workflows.
• Support onboarding activities related to updated document workflows.
• Contribute to continuous improvement of documentation practices during system integration.

Documentation Quality & Compliance

• Ensure documents meet regulatory requirements.
• Ensure documents meet quality system requirements.
• Follow 21 CFR 820 requirements.
• Follow ISO 13485 requirements.
• Follow MDR requirements where applicable.
• Track document status accurately.
• Track project deliverables accurately.
• Support audit readiness activities.
• Support implementation of employee audit awareness programs.
• Strengthen auditor interactions.
• Improve inspection readiness.

Qualifications

• Bachelor's degree in Quality Management, Engineering, Business Administration, or related field.
• Minimum 3–5 years of experience in Documentation Control or Quality Assurance.
• Strong knowledge of documentation control regulations and industry standards.
• Experience with Electronic Document Management Systems (EDMS).
• Windchill experience preferred.
• Excellent written communication skills.
• Excellent verbal communication skills.
• Strong attention to detail.
• Ability to work independently.
• Ability to work as part of a team.

Travel

• None.