Cook Medical Manager, Quality Assurance and Quality Control in Ellettsville, Indiana
The Quality Assurance and Quality Control Manager serves on a cross functional team, ensuring the adequacy, suitability and compliance of specified Quality Management System processes and Quality Engineering decisions. Manages day-to-day quality operations and provides leadership and direction to the functional team.
Approve quality documents, analyze improvement of the QMS and other department processes, including reviewing, updating, creating, and implementing SOP’s to support improved processes and compliance.- Provide quality expertise and leadership to management and operational personnel.- Actively assure operational observance to compliance obligations to include, regulatory, contractual, and SOP driven requirements.- Actively look for ways to improve quality processes and procedures.- Attend, present and provide data for meetings to include project updates and reviews.- Participate in hiring, interviewing and onboarding process of new hires.- Responsible for managing quality engineers and quality control personnel.- Responsible for performance management and annual reviews of direct reports.- Authorization of weekly time sheets.- Develop plans to evaluate improvement projects.- 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, ISO 11135 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.
- Bachelor's degree in Engineering or Life Science or experience of such kind and amount as to provide a comparable background.- Minimum 5 years experience in a regulated industry, preferably in a medical manufacturing environment and EtO sterilization.- Minimum 3 years experience working with quality management system.- Minimum 3 years experience working with EtO sterilization (ISO 11135)- Previous leadership experience.- Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Business Objects.
• Works under general office environment conditions
• Utilizes close visual acuity for working with computers and equipment
• Frequently required to stand, walk, and hear
• Occasionally required to lift up to 20 pounds
Posting Date5 days ago(1/11/2021 9:53 AM)
Job Location(s)Ellettsville IN United States
Position TypeFull Time