Job Title: Internal Auditor, QMS Remediation
Contract: 6+ Months
Location: Wayne, NJ - Hybrid
Description:
One of our Clients is seeking a Senior / Principal-level Internal Auditor to support QMS remediation initiatives for a Class III medical device portfolio. This role is execution-focused and requires deep, hands-on experience conducting internal audits in regulated environments, with an emphasis on QMS effectiveness, design controls, and risk management.
The ideal candidate is a seasoned quality professional who can independently assess complex quality systems, identify systemic gaps, and contribute meaningfully to remediation efforts in a high-visibility environment.
Key Responsibilities:
- Plan, execute, and document internal quality audits supporting remediation and inspection readiness initiatives.
Perform deep-dive audits across core QMS elements, including:
- CAPA
- Complaints
- Design Controls
- Risk Management
- Change Control
- Supplier Quality
- Evaluate QMS design and effectiveness, not just procedural compliance.
- Identify systemic issues, perform root cause analysis, and support development of corrective actions.
- Partner cross-functionally with Quality, Engineering, and Regulatory teams to drive remediation activities.
- Ensure audit outputs are clear, defensible, and inspection-ready.
- Support follow-up activities, including remediation tracking and effectiveness checks.
- Operate independently with minimal oversight in a fast-paced remediation environment.
Required Qualifications:
- 10+ years of experience in Quality within regulated manufacturing environments.
- Strong experience supporting Class III medical devices.
- Extensive hands-on experience conducting internal audits tied to remediation or compliance improvement initiatives.
Deep working knowledge of and certifications in:
- ISO 13485
- FDA QMSR / 21 CFR 820
- MDSAP
- Demonstrated ability to confidently discuss and assess:
- Design Controls
- Risk Management principles
- QMS structure and system effectiveness
Preferred Qualifications
- Formal training, certifications, or strong hands-on experience with ISO 14971 (Risk Management).
- Experience supporting remediation programs following audits or regulatory findings.
Familiarity with:
- TrackWise (QMS) Jama (ALM / Design Controls) Key Traits for Success
- Strong critical-thinking and analytical skills.
- Ability to “dig in” and challenge assumptions during audits.
- Comfortable operating in high-visibility, remediation-driven environments.
- Capable of translating audit findings into actionable remediation steps.
- Credible partner to senior Quality and Engineering stakeholders.
Pay: $80.00 - $90.00 per hour
Work Location: In person
