Senior Quality Investigator & Technical Writer

Fresenius Kabi USA; North Carolina; On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

401(k) plan with company contributions

paid vacation

holiday and personal days

employee assistance program

health benefits to include medical, Rx

dental and vision coverage

life insurance

disability

wellness program

Job summary

Fresenius Kabi USA is seeking a quality investigator to independently oversee the thorough examination of process deviations and customer complaints. You will determine root causes and initiate CAPA actions to address quality deficiencies, aiming to minimize recurrence and potential product actions.

The role requires handling investigations end-to-end with minimal supervision. The position includes accountability for timely investigations, trend-based corrections, and coordination with senior

Responsibilities

• Investigate process deviations and customer complaints, determine root causes and initiate corrective/preventive actions.
• Provide proactive corrections based on trend analysis to reduce recurrence and potential product recalls or field actions.
• Manage investigations from initiation to completion with minimal supervision.
• Assess manufacturing or analytical environments and advise senior management on appropriate actions.

Job description

Fresenius Kabi USA is seeking a quality investigator to independently oversee the thorough examination of process deviations and customer complaints. You will determine root causes and initiate CAPA actions to address quality deficiencies, aiming to minimize recurrence and potential product actions.

The role requires handling investigations end-to-end with minimal supervision. The position includes accountability for timely investigations, trend-based corrections, and coordination with senior