Senior Audit Program Specialist

INTEGRA LIFESCIENCES CORP; Plainsboro Township (NJ); On-site; USD 81,650 - 112,700; Full time

Benefits offered by this job

Medical, dental, vision, and life insurance

401(k) savings plan

Short-term and long-term disability

Job summary

INTEGRA LIFESCIENCES CORP in Plainsboro Township, NJ seeks a Senior Audit Program Specialist to support the internal quality audit program. This role involves coordination and administration across the audit lifecycle, ensuring compliance with FDA, ISO, and global standards.

The ideal candidate will have relevant experience in quality or compliance, strong organizational skills, and proficiency with quality systems. The position offers a competitive salary, benefits, and may require up to 20% travel.

Qualifications

• A minimum of 5 years of experience in quality or compliance roles.
• Experience in FDA controlled environments.
• This position could require up to 20% travel.

Responsibilities

• Coordinate the annual internal audit schedule, approval, and revisions.
• Support audit planning, scope definition, and logistics.
• Prepare audit metrics and dashboards.

Skills

Strong organization and communication skills

Proficiency with quality systems and Microsoft Office

Strong collaboration skills

Education

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

Advanced degree with 3 years of experience in quality or compliance roles

Tools

FDA QMSR

ISO 13485

MDSAP

TrackWise audit module

Job description

Senior Audit Program Specialist

The Senior Audit Program Specialist supports the corporate internal quality audit program within Integra Lifesciences. This role is responsible for supporting the auditor team in coordinating and administering all stages of the corporate internal audit lifecycle, including audit scheduling, planning, execution logistics, report generation, review and approval facilitation, corrective and preventive action (CAPA) tracking, and performance metric reporting. The position ensures audits are conducted in compliance with corporate policies, FDA QMSR, ISO 13485, MDSAP, EU MDR, and other applicable global regulatory requirements.

Essential Duties and 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.
• Support continuous improvement of audit processes, including TrackWise audit module.
• Assist with site‑level preparation for external inspections.
• Perform other related duties as expected.

Desired Minimum Qualifications

• Bachelor’s degree in Engineering, Science, Quality, or related field.
• A minimum of 5 years of experience in quality or compliance roles or an advanced degree with 3 years of experience in quality or compliance roles.
• Experience with FDA QMSR, ISO 13485, MDSAP.
• Strong organization and communication skills.
• Proficiency with quality systems and Microsoft Office.
• Experience in FDA controlled environment.
• Strong collaboration skills and experience working in a matrix environment.
• This position could require up to 20% travel.

Salary

Pay Range: $81,650.00 – $112,700.00 USD.

Individual pay is determined by several factors including job‑related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation.

Benefits

• Medical, dental, vision, and life insurance.
• Short‑term and long‑term disability.
• Business accident insurance and group legal insurance.
• 401(k) savings plan.

EEO Statement

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. Unlawful discrimination or retaliation for asserting a right under a federal, state, or local law is prohibited.