• Job Description

  Req#: 16652

  Overview

  The Quality Assurance Specialist supports organizational quality directives and goals by creating and/or updating Quality Management System (QMS) at Cook Medical LLC.

  Responsibilities

  • Works independently to create and/or update Quality Management System processes using strong understanding of ISO 13485 and applicable regulatory requirements.• Complete tasks to ensure compliance in containment, investigation, and corrective action for the Complaint Handling and CAPA procedures.• Perform risk assessments for complaints, CAPA, audits and advise other functions of new product failure modes or additional risks.• Recommends production and quality documentation updates to support corrective actions and process improvements.• Communicates with customers, suppliers, subcontractors, and company employees regarding product quality failures.• Supports Quality Assurance, Quality Engineering, Operations, and Engineering to complete assigned corrective actions. • Interfaces with external auditors from notified bodies or customers to provide Quality Management System information, evidence, and explanation.• Collects, researches, and analyzes data to provide detailed quality reports or trending data to management.• Prioritize, plan, and execute work activities and assigned projects with minimal supervision in alignment with department and company priorities

  Qualifications

  • Bachelor’s Degree in Business, Science, or Engineering, or equivalent comparable work experience• Quality Management Certification, ASQ Certification, RAB and/or Six Sigma preferred

  • 3+ years of experience with quality management systems in a regulated field• Experience in statistical analysis and analytical reasoning• Proven track record of problem solving

  • Experience with ISO 13485 compliant systems, FDA 21 CFR part 820 compliance preferred• Experience with Corrective/Preventive Action “CAPA” preferred• Experience with the application of Risk Management in a regulated field preferred

  • Thorough understanding of the principles of Quality including documentation, process control, product inspection, and satisfaction of customer requirements• Experience in a manufacturing environment

  • Proficiency with Microsoft Office applications, Excel, and Outlook• Effective communication and writing skills• Good investigation and problem-solving skills

  Physical Requirements:

  • Frequently required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; see; and talk/hear

  • Exerting up to 10 pounds of force occasionally

  • Sedentary work involves sitting most of the time

• About the company

  Cook Group Incorporated is an American privately held company based in Bloomington, Indiana, and primarily involved in manufacturing of medical devices.

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