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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• 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

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and experience required for this position.

• 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 Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/