Director, Quality Remediation & Continuous Improvement

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

Benefits offered by this job

Hybrid work

Competitive bonus

Job summary

Getinge invites a Director, Remediation and Continuous Improvement to lead the remediation program across Acute Care Therapies sites under the FDA Consent Decree. This global role partners with Product Areas, manufacturing sites, and Corporate Quality to drive quality-system improvements and a successful exit from the decree.

The role requires hands-on FDA compliance experience and the ability to build problem-solving capability across ACT with Lean/Six Sigma methods.

Qualifications

• Bachelor’s degree in Engineering or equivalent required.
• Minimum 10 years medical device quality and regulatory compliance experience.
• Demonstrated experience with FDA compliance and enforcement actions.
• Strong leadership, communication, and cross-functional collaboration.

Responsibilities

• Lead remediation program across ACT sites under FDA Consent Decree.
• Drive continuous improvement and alignment with Getinge Quality strategy.
• Engage with FDA and external authorities on remediation status and actions.
• Define and deploy remediation strategy, workplans, and KPIs.
• Ensure remediation outcomes are embedded in GetQMS and compliant with 21 CFR Part 820 and ISO standards.

Skills

Leadership

FDA compliance

Regulatory experience

Project management

Education

Bachelor’s degree in Engineering or equivalent

Tools

GetQMS familiarity

CAPA processes

Job description

Getinge invites a Director, Remediation and Continuous Improvement to lead the remediation program across Acute Care Therapies sites under the FDA Consent Decree. This global role partners with Product Areas, manufacturing sites, and Corporate Quality to drive quality-system improvements and a successful exit from the decree.

The role requires hands-on FDA compliance experience and the ability to build problem-solving capability across ACT with Lean/Six Sigma methods.