Specialist, Quality Engineering

Overview

The Quality Engineering Specialist supports, reviews, and analyzes quality system processes and works with an interdisciplinary team of engineers and specialties along with their department to advance the strategic goals of Quality Engineering.

Responsibilities

• 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.

Qualifications

• 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.