ECO / Test Method Validation (TMV) Coordinator

Key Responsibilities

• Cook up Engineering Change Orders (ECOs).
• Support Test Method Validation (TMV) activities.
• Maintain engineering and quality documentation.
• Collaborate with Engineering, Quality, Manufacturing, and Regulatory teams.
• Support change control and risk management activities.
• Ensure compliance with quality standards and Good Documentation Practices (GDP).

Required Qualifications

• Experience with ECO and/or TMV activities.
• Experience working in a regulated medical device manufacturing environment.
• Knowledge of ISO 9001, ISO 13485, and ISO 14971 standards.
• Familiarity with Good Documentation Practices (GDP).
• Experience supporting FMEA and risk management documentation.
• Proficiency with Microsoft Office applications.
• Strong communication, organizational, and cross-functional collaboration skills.