VALIDATION ENGINEER

Job Description:

• 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 the client’s Production Engineering – Process Validation team.
• 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