at Flextronics International USA, Inc. in Libertyville, Illinois, United States
Job Description
Flextronics International USA, Inc. in Libertyville, IL seeks Validation Engineer:
Develop and execute validation strategies for medical devices, including equipment, processes, and software. Involved in the validation planning process, including risk assessment and validation approach. Create and maintain validation documentation, such as protocols, reports, and change control documentation. Perform validation testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Collaborate with cross-functional teams, including R&D, Quality Assurance, and Regulatory Affairs, to ensure compliance with applicable regulations (e.g., FDA, ISO 13485). Conduct gap analyses and create remediation plans for any non-compliance issues. Stay current with industry trends and regulations to ensure best practices in validation processes.
Minimum Requirements: Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, or related discipline, or foreign equivalent, and 2 years of experience in the job offered or in a closely related position.
Special Requirements: Experience must include 2 years with the following:
- FDA quality system regulation and Good Manufacturing Practices (GMP)
- Authoring and executing validation protocols and reports
- Statistical analysis tools, including Minitab
- Validation software /Test method Validation
Background checks may be required.
Contact: Apply at https://www.jobpostingtoday.com/ Ref# 90678.
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