Our client is seeking a Quality Consultant with strong experience in Corrective and Preventive Actions (CAPAs) and Quality Management Systems (QMS) to support ongoing remediation and compliance activities. The consultant will assist in bringing the QMS up to current standards and ensure CAPAs are compliant, effective, and well-documented.

Responsibilities

• Review, assess, and provide expert guidance on existing and new CAPAs.
• Provide detailed feedback and direction to ensure CAPA documentation meets regulatory expectations.
• Proofread and edit CAPA write-ups and related quality documentation.
• Support QMS remediation activities to align with current regulatory requirements (e.g., FDA, EU MDR, ISO 13485).
• Collaborate with internal teams to ensure timely and effective closure of quality issues.
• Participate in general quality and manufacturing reviews as needed.

Qualifications

• 8+ years of experience in Quality Assurance within the pharmaceutical or medical device industry.
• Expertise in CAPA systems and QMS remediation.
• Strong knowledge of FDA regulations, ISO 13485, and industry best practices.
• Exceptional writing, proofreading, and documentation skills.
• Proven track record supporting audits, inspections, and quality system improvements.

Location

• Waukegan, IL

Employee Type

• W2 or 1099 engagements

Contract Length

• 6-10 months

Compensation

• Hourly rate: $50-$75/hour, depending on experience and qualifications

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled