Director, Remediation & Continuous Improvement (Hybrid)

Getinge Group; Wayne (NJ); Hybrid; USD 200,000 - 240,000; Full time

Job summary

Getinge is seeking a Director, Remediation and Continuous Improvement in Wayne, NJ. The role leads remediation across ACT sites under the FDA Consent Decree, driving quality system improvements and cross‑functional collaboration with manufacturing, Product Areas, and Corporate Quality.

The position requires hands‑on FDA experience and the ability to deploy best practices globally. This hybrid role involves 1–2 days per week in Wayne, NJ, and focuses on remediation strategy, continuous

Qualifications

• Bachelor’s degree in Engineering or equivalent technical discipline.
• Minimum 10 years of medical device quality and regulatory compliance experience.
• Hands‑on experience with FDA compliance and enforcement actions.
• Experience interacting with FDA including inspections and regulatory correspondence.
• Knowledge of FDA requirements (21 CFR Part 820, ISO 13485, ISO 14971).
• Ability to work in a high‑stakes, matrixed, global organization.

Responsibilities

• Drive remediation efforts across Consent Decree sites with integrated workplans and milestones.
• Identify systemic quality gaps before auditors or FDA findings and address at system level.
• Review external audit findings and propose improvements to root cause and CAPA.
• Ensure remediation outcomes are sustainable with objective evidence.
• Report remediation status to ACT and Getinge leadership and escalate risks.
• Support communication with FDA and other external authorities on remediation status.

Skills

FDA compliance

Regulatory compliance

FDA inspections

CAPA

Root cause analysis

Lean Six Sigma

Education

Bachelor’s degree in Engineering

Job description

Getinge is seeking a Director, Remediation and Continuous Improvement in Wayne, NJ. The role leads remediation across ACT sites under the FDA Consent Decree, driving quality system improvements and cross‑functional collaboration with manufacturing, Product Areas, and Corporate Quality.

The position requires hands‑on FDA experience and the ability to deploy best practices globally. This hybrid role involves 1–2 days per week in Wayne, NJ, and focuses on remediation strategy, continuous