Quality Assurance Specialist, Supply Chain

The Quality Assurance Specialist supports organizational quality directives and goals by creating and/or updating Quality Management System (QMS) at Cook Medical LLC. Responsible for our internal audit program, this includes the planning and executing of all internal audits in accordance with ISO 13485:2016 and 21 CFR Part 820, including all nonconformance issuance and follow-up. 

• 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

• 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