Program Manager-Internal Audit (Wayne, NJ)

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

The Program Manager, Internal Audit is responsible for shaping and refining the Acute Care Therapies (ACT) internal audit program, at a Global level, to ensure compliance with applicable medical device regulations and standards across the organization. This includes but is not limited to, ISO 13485, ISO 14971, and 21 CFR Part 820. This role provides strategic oversight of the internal audit schedule, methodology, and program effectiveness while performing selected audits to evaluate the Quality Management System's compliance and efficiency. The position partners closely with cross-functional teams globally, to enhance audit readiness, promote continuous improvement, and ensure consistent alignment with corporate quality and compliance objectives. This role serves as both a program leader and a subject matter expert in medical device quality systems and regulatory compliance, while demonstrating strong interpersonal skills, adaptability, and a collaborative mindset.

This position will be onsite 4 days a week.

Job Responsibilities and Essential Duties

• Manage the internal audit program, including annual planning, scheduling, and resource coordination in accordance with regulatory requirements.
• Oversee the execution of internal audits and perform selected audits to assess compliance with standards such as ISO 13485, ISO 14971, EU MDR, and 21 CFR Part 820.
• Ensure audit activities are conducted in accordance with approved procedures and professional auditing principles.
• Review and approve audit reports and corrective action plans; monitor timely resolution and verification of audit findings.
• Develop and maintain program metrics, dashboards, and management reports to measure program effectiveness and compliance performance.
• Provide training, coaching, and guidance to internal auditors to support capability development and consistency in audit execution.
• Collaborate with Quality Systems, Regulatory Affairs, R&D, Operations, and other departments to drive compliance, audit readiness, and process improvement.
• Serve as a liaison for external audits and regulatory inspections by coordinating internal preparation and documentation.
• Evaluate the impact of regulatory and standard changes on internal audit processes and drive program updates as needed.
• Support management review and quality performance reporting by providing key insights and data from the internal audit program.
• Demonstrate strong communication and relationship-building skills to influence stakeholders and foster a culture of quality and compliance.
• Exhibit adaptability and resilience when managing competing priorities and navigating regulatory changes.
• Apply critical thinking and problem-solving skills to identify systemic issues and implement sustainable improvements.
• Promote teamwork, collaboration, and a positive approach to continuous improvement initiatives.

Required Knowledge, Skills, and Abilities

• Bachelor's Degree in Engineering, Life Sciences, Quality, or a related discipline; advanced degree preferred.
• Minimum of 7 years of experience in quality or compliance within the medical device industry, including direct audit leadership at FDA or Notified Bodies required.
• Comprehensive knowledge of ISO 13485, ISO 14971, 21 CFR Part 820, and medical device regulatory requirements.
• Certified Quality Auditor (CQA) or ISO 13485 Lead Auditor certification required.
• Demonstrated experience in planning, conducting, and leading audits and in interfacing with FDA, Notified Bodies, or similar regulatory authorities.
• Proven ability to manage cross-functional projects, prioritize multiple deliverables, and operate within defined timelines.
• Strong analytical and problem-solving skills with the ability to identify systemic issues and implement effective improvements.
• Excellent communication skills, including executive-level reporting and presentation abilities.
• High emotional intelligence, with the ability to build trust and credibility across diverse teams.
• Strong leadership and influencing skills to drive engagement and accountability.
• Ability to work independently while fostering collaboration and maintaining a proactive, solution-oriented mindset.
• Proficiency with electronic Quality Management Systems (eQMS), audit management software, and Microsoft Office applications.
• Approximately 30% travel requirement to Getinge ACT US sites, as well as International travel

The base salary for the position is a minimum of $140,000 and a maximum of $165,000. plus 15% in annual bonus

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About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.