Quality Assurance Specialist

1 week ago


Bloomington, United States Cook Group Full time
Job Title: Quality Assurance Specialist

At Cook Group, we are seeking a highly skilled Quality Assurance Specialist to join our team. In this role, you will serve as a quality mentor and reviewer for all CAPA and RIC activities. Your primary responsibility will be to perform work per external and internal quality standards, ensuring compliance with FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

Responsibilities:

• Perform quality assessments of root cause analysis of product or process CAPAs.
• Mentor CAPA owners in the use of root cause investigation tools and appropriate implementation activities.
• Drive continuous improvement efforts through facilitating, leading, and collaborating with cross-functional teams, including quality, engineering, production, clinical, and regulatory affairs.
• Provide leadership in the understanding of medical device regulations and best practices.
• Manage conflict resolution as it relates to technical situations.
• Maintain all training requirements for the position while seeking opportunities for continuous development and growth.

Qualifications:

• Engineer degree or a Technical Life Science degree.
• Demonstrates knowledge of medical device regulation (ISO 13485, 21 CFR) and risk management (ISO 14971).
• Professional certification (e.g. ASQ, Six Sigma, etc.) preferred.
• Proficiency in statistical, quality, and continuous improvement methods and tools.
• Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required.
• Strong organizational skills.
• Critical thinking and attention to detail required.
• Excellent verbal communication skills and technical writing.

Physical Requirements:

• Works under general office environmental conditions, including time in manufacturing environment and biohazard lab.
• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Occasional travel may be required.

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