Specialist, Quality Engineering

- 1-2-years of Quality Assurance or relevant experience. - Knowledge of medical device regulations, including pertinent standards. - Computer literacy and proficiency.- Experience in statistical and analytical reasoning preferred.- CQA or like certification preferred.- Bachelor's degree in a technical field or equivalent experience preferred. - Knowledge of Cook quality systems, associated documentation and product lines preferred.

- Drives project improvement initiatives with minimal oversight. - Monitor and report project progress, delays, and completions while involving management at the appropriate times- Investigate quality issues.- Communicate with other departments to identify and troubleshoot project issues.- Provide feedback to management on areas for improvement from a systems and personnel standpoint.- Monitor and maintenance of processes critical to CMLLC Quality Management system.- Participate in internal and external quality assessments/audits.- Must be able to multi-task.- Independently produce and organize and maintain document or systems critical to the foundation of the department. - Lead short term, long term, or system forward projects.- Organize and participate in quality projects.- Understanding of regulatory requirements.- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.- Must strictly adhere to safety requirements.- Maintain regular and punctual attendance.- Must maintain company quality and quantity standards.- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.- Ability to remain calm and receptive in fast paced situations.