Director, Remediation and Continuous Improvement (Wayne,NJ)

Getinge•Wayne, NJ

3d•$200,000 - $240,000•Hybrid

About The Position

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, NJ.

Requirements

Bachelor’s degree in Engineering or an equivalent technical discipline.
Minimum of 10 years of medical device quality and regulatory compliance experience, with progressive leadership responsibility.
Demonstrated, hands-on experience with FDA compliance and enforcement actions, such as consent decrees, warning letters, or other judicial or administrative actions, including leading or materially contributing to remediation and close-out.
Direct experience interacting with FDA, including inspections, regulatory meetings, and written responses to FDA observations or correspondence.
In-depth knowledge of FDA medical device requirements, including 21 CFR Part 820 (QMSR), Part 803 (Medical Device Reporting), Part 806 (Corrections and Removals), and Part 7 (Recalls), as well as ISO 13485 and ISO 14971.
Understanding of FDA’s enforcement tools and processes, and of how the agency evaluates the adequacy of corrective actions and remediation before resolving an enforcement action.
Proven track record as a change leader, with demonstrated results in quality system remediation and continuous improvement.
Expertise in structured problem solving and improvement methods, including CAPA, root cause analysis, Lean, and Six Sigma.
Ability to work effectively within complex, matrixed, global organizations and to collaborate and influence without direct authority.
Strong interpersonal skills, including communication, facilitation, consulting, coaching, and influencing at all levels, including executive leadership and regulators.
Clear, precise written communication, including the ability to draft accurate and defensible regulatory correspondence.
Demonstrated ability to work under tight deadlines and manage multiple complex, detail-oriented priorities.
Sound, risk-based judgment that puts patient safety and product quality first.

Nice To Haves

Prior experience at FDA (for example, as an investigator, compliance officer, or reviewer), or as a third-party expert auditor or consultant supporting consent decree remediation.
Experience supporting a company through a successful consent decree exit or warning letter close-out.
Experience with Class II and Class III cardiovascular or critical care devices.

Responsibilities

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.
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.
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.
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.
Provide strategic and project leadership through proactive, clear communication of requirements, risks, and milestones. Accountable for remediation and continuous improvement deliverables and objectives within the ACT Quality & Regulatory organization.
Lead, mentor, and coach team members, and provide direction, oversight, training, and development to ensure compliance with external standards and internal procedures.
Work with cross-functional teams to create and sustain process and quality improvements at individual sites and across ACT.
Build credibility and trust with internal and external stakeholders through regular communication and proven performance.
Promote a quality culture in which patient safety and product quality come first, regulatory compliance is the minimum standard, and every function owns accountability for compliance, accuracy, consistency, and completeness.