What are the responsibilities and job description for the Senior GMP Auditing Consultant position at Redbock - an NES Fircroft company?
Duration: 5-month contract through end of 2026
Location: Remote with occasional travel to Client facility in Orange County (approximately one week per audit). Important to note that not every audit will require a full week of onsite presence. Local consultants requiring minimal travel cost are highly preferred.
Estimated workload: 20-30 hours/week
Overview
Our medical device client is seeking a Senior GMP Quality Auditor to lead a series of internal quality system audits supporting global compliance initiatives. This consultant will work alongside two existing internal auditors to plan and execute audits across multiple functional areas, assess compliance with applicable global regulations, identify quality and compliance risks, and provide actionable recommendations to strengthen the organization's Quality Management System.
Responsibilities
- Lead and execute four internal GMP audits across distribution/warehouse operations, work environment and laboratory controls, pilot and metals manufacturing, and design development.
- Evaluate compliance with MDSAP, ISO 13485, ISO 14971, EU MDR, 21 CFR Part 820, and other applicable global regulatory requirements.
- Apply a risk-based auditing approach to identify compliance gaps and improvement opportunities.
- Prepare audit plans, conduct onsite and remote audit activities, document findings, and present recommendations to leadership.
- Partner with cross-functional Quality, Manufacturing, Engineering, and Operations teams to ensure audit readiness and support remediation activities.
Qualifications:
- 10–15 years of Quality Assurance and GMP auditing experience within the medical device industry.
- Extensive experience leading internal quality system audits.
- Strong working knowledge of MDSAP, ISO 13485, ISO 14971, EU MDR, 21 CFR Part 820, and global medical device quality regulations.
- Class III medical device experience is preferred.
- Excellent communication, facilitation, and stakeholder management skills.
- Ability to independently assess risk, challenge existing processes, and provide practical recommendations for continuous improvement.
- Experience with Windchill PLM and ETQ is preferred
- Lead Auditor certification (ISO 13485 or equivalent) preferred