Senior Quality Investigations & CAPA Writer

Fresenius; Wilson (NC); Vor Ort; USD 74.000 - 104.000; Vollzeit

Benefits dieser Stelle

401(k) with company contributions

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

Wellness program

Zusammenfassung

Fresenius Kabi in Wilson, NC seeks a dedicated investigator to independently conduct thorough investigations of process deviations and customer complaints. You will determine root causes, initiate CAPAs, and provide proactive corrections based on trends to prevent recurrence, working with minimal supervision to drive investigations from start to finish.

The role offers a comprehensive benefits package and eligibility for a bonus plan; final pay depends on experience, education, and abilities.

Qualifikationen

• Experience conducting root-cause analysis for process deviations and customer complaints.
• Ability to perform risk assessments on products, processes and patient safety implications.
• Proficiency with documenting and communicating findings to senior management.

Aufgaben

• Investigate deviations and complaints; determine root cause and initiate CAPA.
• Gather information from internal and external sources to assess impact on product and operations.
• Use structured tools to identify root causes and present findings to management.
• Advise on corrective/preventive actions to mitigate deficiencies identified in investigations.
• Maintain and update enterprise quality management systems and perform trend analyses.

Kenntnisse

Root-cause analysis

Risk assessment

Data analysis

Technical expertise

Quality management systems

Trend analysis

Tools

SOP compliance

Jobbeschreibung

Fresenius Kabi in Wilson, NC seeks a dedicated investigator to independently conduct thorough investigations of process deviations and customer complaints. You will determine root causes, initiate CAPAs, and provide proactive corrections based on trends to prevent recurrence, working with minimal supervision to drive investigations from start to finish.

The role offers a comprehensive benefits package and eligibility for a bonus plan; final pay depends on experience, education, and abilities.