Process Validation Engineer (Medical)

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• Review of process validations for identification of gaps to internal and external requirements.
• Test Method Validation and Process Validation protocol generation, execution, and report generation per applicable Quality System Procedures and Instructions
• This Engineering position will work within Pk48 Production Engineering - Process Validation
• Department and with other functional groups, as needed, to identify process validation needs.
• Demonstrate the understanding of medical device regulations and best practices.
• Demonstrate knowledge of medical device regulation (ISO 13485, 21 CFR) and risk management (ISO 14971).
• Demonstrate a proficiency in statistical, quality and continuous improvement methods and Tools.