Quality Validation Engineer II - Intellectt INC

Job Title: Quality Validation Engineer
Location: Holdrege, NE on W2

Key Responsibilities:

• Develop and execute validation plans, protocols, and reports for manufacturing processes, equipment, and systems.
• Perform risk assessments and ensure that validation activities align with regulatory standards (FDA, ISO, etc.).
• Review and approve validation documentation, including URS, IQ, OQ, and PQ protocols.
• Collaborate with engineering, manufacturing, and quality assurance teams to resolve validation issues and ensure quality compliance.
• Conduct regular audits of validation processes and documentation to identify areas for improvement.
• Provide training and support to team members on validation procedures and best practices.
• Maintain up-to-date knowledge of industry trends, regulatory changes, and validation methodologies.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field.
• Minimum of 3 years of experience in quality validation within the medical device industry.
• Strong understanding of validation processes, methodologies, and regulatory requirements (FDA, ISO 13485).
• Proficient in quality management systems and tools (e.g., CAPA, Change Control).
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills to work effectively in a team environment.