Quality Engineer - Critical Systems & GMP Compliance

Fresenius Kabi; Melrose (MA); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

401(k) with company contributions

Wellness program

Medical, dental, vision coverage

Job summary

Fresenius Kabi in Melrose, MA is seeking a Primary Quality Owner for plant facilities, utilities, and equipment. You will oversee quality processes, validations, and documentation to ensure regulatory compliance and continuous improvement across critical systems.

The role requires 5+ years in a regulated pharma setting, with strong experience in validation, cGMP, and change control. A collaborative, cross-functional approach will drive quality across engineering, operations, and maintenance.

Qualifications

• B.S. degree in a technical science is required; engineering degree strongly preferred.
• Minimum 5 years in a highly regulated industry; pharmaceutical experience preferred.
• Experience in qualification and validation practices required; knowledge of cGMP, FDA guidelines, ISO is essential.

Responsibilities

• Own quality aspects of critical plant systems and associated processes; ensure compliance and approvals for maintenance and validations.
• Lead change control for critical systems including timely pre- and post-approval of changes.
• Provide quality oversight for software validations, equipment qualifications, and facility commissioning.
• Investigate events, CAPA, root-cause analyses, and risk assessments to prevent defects.
• Collaborate with engineering, maintenance, and operations to monitor Facility Monitoring System alarms and trends.
• Provide training on critical quality systems and maintain metrics for continuous improvement.

Skills

Quality ownership

Regulatory compliance

CAPA

Root cause analysis

Continuous improvement

Six Sigma

Lean manufacturing

Change control

Education

B.S. in technical sciences

Engineering degree preferred

Tools

Validation practices

Aseptic processing knowledge

Job description

Fresenius Kabi in Melrose, MA is seeking a Primary Quality Owner for plant facilities, utilities, and equipment. You will oversee quality processes, validations, and documentation to ensure regulatory compliance and continuous improvement across critical systems.

The role requires 5+ years in a regulated pharma setting, with strong experience in validation, cGMP, and change control. A collaborative, cross-functional approach will drive quality across engineering, operations, and maintenance.