Director, Design Quality & Compliance (Hybrid)

Fresenius Kabi USA, LLC; Suttons Mills (MA); Hybrid; USD 185,000 - 205,000; Full time

Benefits offered by this job

Medical, dental & vision coverage

401(k) with company contributions

Wellness program

Hybrid work model

Job summary

Fresenius Kabi USA, LLC seeks a Director of Design Assurance & Site Quality to lead the Design Center's quality program and the local QMS. You will own Design Controls, Risk Management, Design Transfer, Supplier Quality, and Audit readiness, ensuring products are safe, effective, and compliant across the lifecycle.

Hybrid role with onsite 3 days/week in the US, salary range $185,000-$205,000 plus a target bonus of 16%.

Qualifications

• Experience managing a design quality organization.
• Knowledge of medical device regulations (FDA, ISO 13485, MDR).
• Experience with Infusion Pumps is preferred.
• Strong leadership and cross-functional influence.
• English proficiency required for global operations.

Responsibilities

• Lead site Quality organization, including Design Assurance and QMS.
• Own and implement Design Controls and risk management.
• Oversee Design Transfer to manufacturing.
• Prepare for FDA inspections and Notified Body audits.
• Drive continuous improvement and CAPA effectiveness.

Skills

Leadership

Quality Management

Regulatory Knowledge

FDA Inspections

Team Building

Job description

Fresenius Kabi USA, LLC seeks a Director of Design Assurance & Site Quality to lead the Design Center's quality program and the local QMS. You will own Design Controls, Risk Management, Design Transfer, Supplier Quality, and Audit readiness, ensuring products are safe, effective, and compliant across the lifecycle.

Hybrid role with onsite 3 days/week in the US, salary range $185,000-$205,000 plus a target bonus of 16%.