Quality Assurance Specialist, Supply Chain - #258884
Cook Medical
Date: 23 hours ago
City: Bloomington, IN
Contract type: Full time
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
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
- 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
- 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
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