The Quality Assurance Specialist supports quality systems processes and produces and reviews quality records.
Responsibilities• Work with quality systems teams to run reports, create, track, and analyze metrics, facilitate meetings, and document meeting actions• Author, route, and/or review quality systems records for submission to both internal and external customers• Assist in investigating quality issues, as required• Monitor and maintain compliance to existing quality system processes• Assist in internal and external audits• Assist in authoring and/or routing changes to quality system processes
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization• Must strictly adhere to safety requirements• Maintain regular and punctual attendance• Must maintain company quality and quantity standards• Must have excellent oral and written communication skills, specifically related to technical writing• Ability to work in collaborative and independent work situations and environments with minimal supervision • Ability to remain calm and receptive in fast paced situations• Must have excellent organization and prioritization of tasks
Qualifications• Bachelor’s degree ; or 5 - 8 years experience of such kind and amount as to provide a comparable background• Knowledge of Cook Inc. quality systems, associated documentation, and product lines • Knowledge of medical device regulations, including pertinent standards and guidances
• Computer literacy and proficiency (Word, excel, Adobe etc.)
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What We Do
At Cook, we are building our future on Invention, Connection, People, and Community. As a privately owned company, we can look at the world our own way and do what we feel passionate about. What are we passionate about? That’s simple: Making unique, quality products and connecting with people to improve lives on both sides of the device. Central to our focus on building deep connections is our belief in the importance of identifying innovative solutions to help customers, patients, employees, and communities thrive. We understand that our ongoing success will come from creating inclusive, supportive, and healthy environments where we can prosper together. Our people are our greatest asset and are at the heart of everything we do. Come build with us.
