Changing lives. Building Careers.
Joining 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 what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
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 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.
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/
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. If you'd 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 [email protected].
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
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