Senior Audit Program Specialist

divh2Senior Audit Program Specialist/h2pJoining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care./ppThe 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./ph3Essential Duties and Responsibilities/h3pTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily./pulliCoordinate the annual internal audit schedule, approval, and revisions/liliSupport audit planning, scope definition, agenda creation, and audit logistics/liliFacilitate audit execution for onsite and remote audits/liliSupport auditors with drafting audit reports/liliManage cross-functional review and approval of audit reports/liliTrack auditee responses and audit action item status/liliMaintain audit records and databases/liliResponsible for auditor training and certification maintenance/liliPrepare audit metrics and dashboards/liliSupports continuous improvement of audit processes including TrackWise audit module/liliAssists with site-level preparation for external inspections/liliPerform other related duties as expected/li/ulh3Desired Minimum Qualifications/h3pThe requirements listed below are representative of the knowledge, skill, and experience required for this position./pulliBachelors degree in Engineering, Science, Quality, or related field/liliA 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./liliExperience with FDA QMSR, ISO 13485, MDSAP/liliStrong organization and communication skills/liliProficiency with quality systems and Microsoft Office/liliExperience in FDA controlled environment/liliStrong collaboration skills and experience working in a matrix environment/liliThis position could require up to 20% travel./li/ulpSalary Pay Range: $81,650.00 - $112,700.00 USD Salary/ppOur 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 training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process./ppAdditional 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))./ppIntegra 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. If youd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at View email address on click.appcast.io./p/div