Senior Quality Audit Program Lead

Integra LifeSciences Corporation; Plainsboro Township (NJ); On-site; USD 82,000 - 113,000; Full time

Job summary

Integra LifeSciences Corporation in Plainsboro, NJ, seeks a Senior Audit Program Specialist to support the corporate internal quality audit program. You will coordinate scheduling, planning, and logistics across global sites.

The role requires 5+ years in quality/compliance, with knowledge of FDA QMSR, ISO 13485, MDSAP, and EU MDR. Strong organization, MS Office skills, and up to 20% travel are expected.

Qualifications

• Bachelor’s degree in Engineering, Science, Quality, or related field required.
• Minimum 5 years in quality or compliance roles, or 3 years with advanced degree.
• Experience with FDA QMSR, ISO 13485, MDSAP, EU MDR preferred.
• Strong organizational and communication abilities are essential.
• Experience in FDA controlled environments and matrix organizations a plus.

Responsibilities

• Coordinate the annual internal audit schedule, approvals, and revisions.
• Support audit planning, scope, agenda, and logistics for onsite and remote audits.
• Draft and review audit reports; manage cross-functional approvals.
• Track audit responses and CAPA status; maintain audit records and dashboards.
• Support site preparation for external inspections and continuous improvement.

Skills

Strong organization

Communication skills

Audit coordination

Quality systems

Microsoft Office

Education

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

Advanced degree with 3 years of quality/compliance experience

Tools

TrackWise

Microsoft Office

Job description

Integra LifeSciences Corporation in Plainsboro, NJ, seeks a Senior Audit Program Specialist to support the corporate internal quality audit program. You will coordinate scheduling, planning, and logistics across global sites.

The role requires 5+ years in quality/compliance, with knowledge of FDA QMSR, ISO 13485, MDSAP, and EU MDR. Strong organization, MS Office skills, and up to 20% travel are expected.