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Cook Medical Manager, Quality Assurance and Quality Control in Ellettsville, Indiana

Overview

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.

Responsibilities

  • 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.

Qualifications

  • 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.

Physical Requirements:

• 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 Date1 week ago(1/11/2021 9:53 AM)

Requisition ID2021-8314

Job Location(s)Ellettsville IN United States

Travel10-20%

Shift TypeFirst

Position TypeFull Time

CompanyCook Inc.

CategoryQuality

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