Principal Engineer, Quality
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POST DATE 9/17/2016
END DATE 10/18/2016
Fresenius Kabi USA, LLC
Lake Zurich, IL
JOB DESCRIPTIONWe currently have an opportunity for a Quality Engineer in the Medical Device Division who will analyze, develop, implement, and execute processes to ensure product quality.
Develop, implement, and monitor various quality metrics. Identify opportunities for continuous improvement and customer satisfaction. Compile and represent data for monthly CAPA Review and Product Review meetings, as well as annual reports.
Gather and analyze data for root cause analysis. Coordinate and drive efforts to assure CAPAs are opened and completed appropriately. Work with Engineering and Manufacturing to develop and implement corrective actions.
Support complaint sample evaluations and investigations. Track complaint data to identify actionable trends. Respond to customer and regulatory inquiries. Perform risk assessments and analysis .
Serve as quality representative for New Product Development. Contribute to requirements definitions and ensure that reliability, quality, and safety requirements are met. Work closely with Engineering to develop test protocols and reports.
Actively contribute to Change Review Board as part of change control process.
Ensure compliance to regulatory requirements. Uphold quality system. Support internal and external audits.
Work in a cross-functional team environment including members from Manufacturing, Clinical, Regulatory, and Marketing.
Fresenius Kabi offers an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.