Program Manager-Internal Audit (Wayne, NJ)
- 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.
- 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
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
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