What are the responsibilities and job description for the Internal Auditor position at Grove?
Title: MDSAP Internal Auditor Consultant
Location: Mount Prospect,Illinois (2–3 days) - MUST be local
Overview
Our client is seeking an experienced Internal Auditor to conduct an independent audit of its Quality Management System against ISO 13485 and MDSAP requirements. The organization manufactures products and components that support Class I, II, and III medical devices and requires an auditor who can independently plan, execute, and document the audit while providing objective feedback on QMS effectiveness and compliance.
The engagement is expected to be primarily onsite and will require approximately 2–3 audit days.
Responsibilities
- Plan and execute an internal audit of the Quality Management System in accordance with ISO 13485 and MDSAP requirements.
- Develop and utilize an audit checklist and audit methodology appropriate for the scope of the engagement.
- Conduct interviews with Quality, Operations, Manufacturing, and supporting functional teams.
- Review quality system documentation, procedures, records, and supporting evidence.
- Assess compliance with applicable ISO 13485 and MDSAP requirements.
- Identify gaps, observations, nonconformities, and opportunities for improvement.
- Prepare a comprehensive audit report and present findings to Quality Management.
- Provide recommendations to support audit readiness and continuous improvement initiatives.
Required Qualifications
- Must possess a proven audit methodology and be able to provide their own audit plan, checklists, interview guides, and reporting templates.
- Demonstrated experience conducting ISO 13485 internal audits within medical device manufacturing environments.
- Strong working knowledge of MDSAP requirements and audit approaches.
- Previous experience serving as a Lead Auditor, Internal Auditor, or Quality Consultant supporting medical device organizations.
- Experience auditing Quality Management Systems supporting Class I, II, and/or III medical devices.
- Ability to independently develop and execute audit plans, checklists, and audit reports.
- Strong communication and stakeholder management skills.
Preferred Qualifications
- ISO 13485 Lead Auditor certification.
- ASQ Certified Quality Auditor (CQA) or equivalent certification.
- Previous MDSAP audit experience.
- Experience supporting contract manufacturers, component manufacturers, or supplier organizations serving the medical device industry.
- Local to Illinois or able to travel onsite with minimal expense.
Deliverables
- Audit plan and schedule.
- Audit checklist(s).
- Conduct of onsite internal audit activities.
- Audit report summarizing findings, observations, and recommendations.
- Management debrief and review of audit results.
Pay: $80.00 - $85.00 per hour
Benefits:
- Flexible schedule
Work Location: In person
Salary : $80 - $85