1099 CONTRACTOR - Quality & Regulatory Compliance Specialist

Westone Laboratories Inc•Colorado Springs, CO

5h•Remote

About The Position

The Quality & Regulatory Compliance Specialist (Contractor) will provide independent support to maintain and enhance the company’s Quality Management System (QMS) and ensure alignment with ISO standards and applicable FDA regulations. This role operates as an independent contractor and is responsible for delivering defined quality and regulatory outcomes, including audit readiness, document control, and compliance support.

Requirements

Bachelor’s degree in Quality, Engineering, Regulatory Affairs, or related field preferred
3–5+ years of experience supporting ISO quality systems and/or FDA-regulated environments
Demonstrated experience with:
ISO Quality Management Systems (e.g., ISO 9001 or similar)
FDA regulatory compliance
CAPA processes
Internal auditing
Document control systems
Strong organizational, documentation, and audit readiness skills
Ability to work independently and manage deliverables with minimal supervision
Strong communication skills to interface with operational teams

Responsibilities

Maintain and support the company’s ISO Quality Management System (QMS) to ensure compliance with applicable standards
Manage and organize document control systems, including procedures, work instructions, forms, and quality records
Plan, coordinate, and/or conduct internal quality audits; support external ISO certification audits as needed
Track, investigate, and document Corrective and Preventive Actions (CAPA) and ensure timely resolution
Maintain regulatory documentation and support compliance with applicable FDA regulations
Assist in the preparation and maintenance of regulatory filings, product documentation, and registrations
Support responses to regulatory inquiries, inspections, or audits, including documentation preparation
Monitor adherence to quality standards, regulatory requirements, and internal processes
Maintain records related to audits, compliance activities, and quality system performance
Collaborate with cross-functional teams to ensure processes align with quality and regulatory expectations
Assist in the development and revision of quality procedures and work instructions
Provide guidance and training (as requested) on quality systems and regulatory requirements
Recommend and support continuous improvement initiatives related to quality and compliance