Getinge · 2 weeks ago
Program Manager - Internal Audit (Wayne, NJ)
Wayne, NJ
Full-time
Onsite
Senior Level
$140K/yr - $165K/yr
7+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. The Program Manager, Internal Audit will shape and refine the internal audit program to ensure compliance with medical device regulations and standards, while collaborating with cross-functional teams to enhance audit readiness and promote continuous improvement.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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
Qualification
Required
Bachelor's Degree in Engineering, Life Sciences, Quality, or a related discipline
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
Preferred
Advanced degree preferred
Benefits
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Company
Getinge
Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$539.31M2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO
Leadership Team
C
Christoffer Å.
Chief Information Security Officer
Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
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2025-12-19
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