Director, Remediation and Continuous Improvement

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.

Position Summary The Director, Remediation and Continuous Improvement leads the remediation program across Acute Care Therapies (ACT) sites operating under the FDA Consent Decree and sets the direction for Quality & Regulatory continuous improvement across the business area. This global role partners with Product Areas, manufacturing sites, and Getinge Corporate Quality to deliver quality system improvements that protect patients, hold up under independent and FDA scrutiny, and support a successful exit from the Consent Decree.

The Director owns remediation strategy and execution, drives improvement in quality and regulatory systems, and supports communication with FDA and other external authorities. The role also builds problem-solving capability across ACT and drives horizontal deployment of best practices in line with the Getinge Quality strategy and GetQMS. The successful candidate brings direct, hands-on experience with FDA compliance and enforcement and understands what the agency expects to see before an enforcement action can be resolved.

This is a hybrid role, with 1-2 days a week in Wayne, NJJob Responsibilities & Essential Duties Consent Decree Remediation and Exit Readiness Drive ACT remediation efforts across Consent Decree sites, including remediation strategy, integrated workplans, milestones, resourcing, and risk-based prioritization.

Drive proactive remediation: identify systemic quality system gaps before third-party auditors or FDA find them, and correct them at the system level rather than record by record.

Review external audit findings related to Consent Decree exit and quality improvement. Evaluate the resulting corrective actions and recommend improvements to problem definition, root cause, corrective action, and effectiveness verification.

Ensure remediation outcomes are sustainable, supported by objective evidence, and defensible under third-party expert review and FDA inspection.

Report remediation status, risks, and milestone performance to ACT and Getinge leadership, and escalate issues that threaten Consent Decree commitments or timelines.

FDA and External Engagement Support communication with FDA, third-party expert auditors, Notified Bodies, and other external authorities on remediation status, audit findings, and corrective actions.

Contribute to Consent Decree deliverables and regulatory correspondence, including responses to audit and inspection observations, remediation workplans, and periodic status reports.

Apply knowledge of FDA enforcement practice to anticipate how findings will be viewed by the agency and to shape response strategy accordingly.

Continuous Improvement Strategy and Deployment Lead the ACT Quality & Regulatory Continuous Improvement initiatives and define the improvement strategy and roadmap in alignment with Getinge enterprise priorities.

Build structured problem-solving capability across ACT sites and functions, including root cause analysis, A3 thinking, and Lean and Six Sigma methods.

Drive horizontal deployment of lessons learned, remediation solutions, and best practices across ACT Product Areas and sites, and benchmark internal and external organizations to bring proven practices into ACT.Partner with Continuous Improvement leaders across Getinge to deploy improvement tools consistently and deliver measurable, efficient outcomes.

Establish measures that show whether remediation and improvement efforts are improving product quality and quality system performance, not only whether activities were completed.

Quality System Integration Partner with Corporate Quality on GetQMS procedures and tools, and support implementation of the Getinge Quality strategy and GetQMS within ACT.Ensure remediation outcomes are embedded in the quality management system and aligned with 21 CFR Part 820 (QMSR), ISO 13485, and ISO 14971.Provide direction and feedback to the individual, team, and organizational development efforts needed to execute the Quality strategy.

Leadership and Culture Provide strategic and project leadership through proactive, clear communication of requirements,…