1099 CONTRACTOR - Quality & Regulatory Compliance Specialist at Westone Laboratories Inc – Colorado Springs, Colorado

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.

SCOPE OF WORK / KEY DELIVERABLES:

The contractor will provide services that may include, but are not limited to:

• 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

CONTRACTOR QUALIFICATIONS:

• 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

ENGAGEMENT TERMS:

• Classification: Independent Contractor (1099)
• Schedule: Project-based; hours determined by the contractor based on deliverables
• Location: Primarily remote with occasional on-site support as needed
• Duration: Ongoing as needed
• Compensation: Hourly or project-based rate (to be agreed upon)
• Travel: Limited, as required for audits or operational support

INDEPENDENT CONTACTOR STATEMENT:

This role is a contract engagement and does not constitute an employment relationship. The contractor is responsible for determining the method and means of performing the work, maintaining appropriate insurance, and fulfilling all tax obligations associated with independent contractor status.

WORK ENVIRONMENT:

Work may be performed remotely and/or on-site, with periodic interaction with production and operations teams. Occasional presence in manufacturing environments may be required to support audits and compliance activities.