Senior Audit Program Lead - Quality & Compliance

Integra LifeSciences Corporation; Columbia (MD); On-site; USD 82,000 - 113,000; Full time

Job summary

Integra LifeSciences Corporation is seeking a Senior Audit Program Specialist to support the corporate internal quality audit program. This role coordinates schedules, plans audits, and ensures compliance across FDA QMSR, ISO 13485, and MDSAP.

You will facilitate both onsite and remote audits, assist in CAPA tracking, and prepare performance dashboards while collaborating in a matrix organization. This position may require travel to multiple facilities.

Qualifications

• Bachelor’s degree in Engineering, Science, Quality, or related field.
• Minimum 5 years in quality or compliance roles or an advanced degree with 3 years in quality/compliance roles.
• Experience with FDA QMSR, ISO 13485, MDSAP.
• Strong organization and communication skills.
• Proficiency with quality systems and Microsoft Office.
• Up to 20% travel may be required.

Responsibilities

• Coordinate the annual internal audit schedule, approval, and revisions.
• Support audit planning, scope definition, agenda creation, and audit logistics.
• Facilitate audit execution for onsite and remote audits.
• Support auditors with drafting audit reports.
• Manage cross-functional review and approval of audit reports.
• Track auditee responses and audit action item status.
• Maintain audit records and databases.
• Responsible for auditor training and certification maintenance.
• Prepare audit metrics and dashboards.
• Supports continuous improvement of audit processes including TrackWise audit module.
• Assists with site-level preparation for external inspections.
• Perform other related duties as expected.

Skills

Organization & communication

Regulatory knowledge

Matrix collaboration

Travel readiness

Education

Bachelor’s degree in Engineering, Science, Quality or related field

Tools

Microsoft Office

Job description

Integra LifeSciences Corporation is seeking a Senior Audit Program Specialist to support the corporate internal quality audit program. This role coordinates schedules, plans audits, and ensures compliance across FDA QMSR, ISO 13485, and MDSAP.

You will facilitate both onsite and remote audits, assist in CAPA tracking, and prepare performance dashboards while collaborating in a matrix organization. This position may require travel to multiple facilities.