Director, Quality Remediation & Continuous Improvement

Getinge; Wayne (NJ); Híbrido; USD 200.000 - 240.000; Jornada completa

Descripción de la vacante

Getinge is seeking a Director, Remediation and Continuous Improvement to lead remediation across ACT sites under FDA Consent Decree. Hybrid role with 1–2 days per week in Wayne, NJ. You will drive quality improvements, engage with FDA and auditors, and deploy Getinge's quality strategy globally.

You should bring 10+ years in medical device quality and regulatory roles, deep FDA knowledge, and proven leadership to improve FDA readiness and process excellence.

Formación

• Bachelor’s degree in Engineering or equivalent technical discipline.
• Minimum of 10 years of medical device quality and regulatory compliance experience, with leadership responsibility.
• Hands-on experience with FDA compliance and enforcement actions including remediation and close-out.
• Direct experience interacting with FDA, inspections, regulatory meetings, and FDA correspondence.
• Knowledge of FDA requirements (21 CFR 820, 803, 806) and ISO 13485/14971.
• Proven change leadership with quality system remediation and continuous improvement.

Responsabilidades

• Drive remediation strategy across Consent Decree sites with milestones and resourcing.
• Identify systemic quality gaps and correct at the system level.
• Interface with FDA, auditors, and external authorities on remediation status.
• Lead continuous improvement initiatives and deploy best practices across ACT.
• Partner with Getinge Quality to implement GetQMS and ensure compliance.
• Provide leadership and coaching to cross-functional teams and stakeholders.

Conocimientos

Leadership

Regulatory knowledge

Structured problem solving

Communication

Educación

Bachelor’s degree in Engineering

Herramientas

GetQMS procedures

Lean Six Sigma

CAPA

Descripción del empleo

Getinge is seeking a Director, Remediation and Continuous Improvement to lead remediation across ACT sites under FDA Consent Decree. Hybrid role with 1–2 days per week in Wayne, NJ. You will drive quality improvements, engage with FDA and auditors, and deploy Getinge's quality strategy globally.

You should bring 10+ years in medical device quality and regulatory roles, deep FDA knowledge, and proven leadership to improve FDA readiness and process excellence.