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Quality Assurance Specialist

2 months ago

Bloomington Indiana, United States Cook Group Full time

About the Role:

The Quality Assurance Specialist at Cook Group serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA. This role is responsible for ensuring the highest level of quality in our products and processes.

Key Responsibilities:

  • Perform work per external and internal quality standards, ensuring compliance with regulatory requirements.
  • Interface with internal and external groups on quality-related issues, fostering collaboration and effective communication.
  • Support product development and transfer to manufacturing, ensuring seamless integration and quality control.
  • Facilitate development and implementation of production controls, including qualification, process capability, sampling plans, validation, and risk management.
  • Investigate product nonconformance/complaints, perform root cause analysis, and monitor/trend process and product performance.
  • Escalate identified issues and plan, review, and approve change requests, ensuring timely and effective resolution.
  • Execute risk assessment as needed and facilitate development and completion of risk file documentation, ensuring compliance with regulatory requirements.
  • Conduct risk-based decision making and effective resolution of issues, prioritizing quality and safety.
  • Lead or support CAPAs as necessary, ensuring timely and effective resolution.
  • Interface with internal or 3rd party audits, ensuring compliance with regulatory requirements.
  • 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, ensuring compliance and quality.
  • Manage conflict resolution as it relates to technical situations, ensuring effective and professional communication.
  • Maintain a safe working environment, adhering to safety requirements and protocols.

Requirements:

  • Bachelor's degree in a relevant field, such as engineering.
  • Demonstrated knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971).
  • Professional certification (e.g., ASQ, Six Sigma) 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.
  • Excellent verbal communication skills and technical writing.

Working Conditions:

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